Anemia
Conditions
Brief summary
This is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, pharmacokinetics, and pharmacodynamic effects of multiple doses of COR-001 or placebo
Interventions
DRUGCOR-001
OTHERPlacebo
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age greater than or equal to 18 years at the time of signing of the ICF. 2. The patient agrees to comply with the contraception and reproduction restrictions of the study 3. Receiving intravenous (IV) or subcutaneous (SC) erythropoietin stimulating agents (ESA) drugs continuously prescribed for a minimum of 8 weeks prior to Screening 4. At least 2 ferritin values during Screening \> 300 ng/mL 5. At least 2 transferrin saturation (TSAT) values during Screening between 15% and 50% (inclusive)
Exclusion criteria
1. Use of systemic immunosuppressive drugs during the Screening Period or anticipated use of such drugs any time during the study 2. Clinical evidence or suspicion of active or smoldering infection by clinical or serologic criteria 3. Actively treated or active malignancy 4. Known or suspected occult or active bleeding 5. Received a red blood cell or whole blood transfusion within 2 months prior to Screening or anticipated to receive a blood transfusion at any time during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characterization of Maximum Tolerated Dose (MTD) | Weeks 0-24 | The MTD assessment was based on safety data. If more than 2 of 8 active participants in a cohort experience a Dose-Limiting Toxicities (DLT), the MTD was considered to have been exceeded. The DLT threshold was defined using a threshold of greater than or equal to (\>=) Grade 3 events, which includes severe: infusion-related reactions, cardiopulmonary infusion reactions, anaphylaxis, or hypersensitivity. DLTs are defined as follows: 1. Confirmed Grade 3 neutropenia and representing a decline of \> 25% from baseline 2. Serious adverse events (SAEs) of infection in the presence of confirmed Grade 2 or higher new onset lymphopenia or new onset neutropenia. 3. ≥ Grade 3 ALT (Alanine transaminase) or AST(Aspartate transaminase) 4. ≥ Grade 4 hematologic toxicity 5. ≥ Grade 3 non-hematologic toxicity |
| Change in High-sensitivity C-reactive Protein (hsCRP): Week 4 | From baseline (mean of screening and day 1) to week 4 | Change from the baseline in hsCRP values to week 4 are presented. |
| Change in Serum Amyloid A (SAA): Week 4 | From baseline (mean of screening and day 1) to week 4 | Change from the baseline in serum amyloid A (SAA) values to week 4 are presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Electrocardiogram (ECG) | At baseline, week 6, week 12, week 18 and week 24 | A summary of the overall ECG interpretation and clinical significance from baseline until the end of the safety follow up period (week 24) is presented and categorized as Normal, Abnormal clinically significant (CS), Abnormal non clinically significant (NCS) and Missing. |
| Number of Participants Who Developed Anti-drug Antibodies (ADAs) | Weeks 0-35 | Number of participants who developed ADAs from baseline until the end of the extended follow up period (week 35) were reported. Samples with detectable ADAs were classified as positive for ADAs. Samples without detectable ADAs were classified as negative for ADAs. |
| Number of Participants With ADA Titers | Weeks 0-35 | Number of participants with ADA titers for ADA-positive samples from baseline to week 35 is presented. |
| Number of Participants With Neutralizing ADAs | From baseline (mean of screening and week 1) to week 35 | Number of participants with neutralizing ADAs from baseline to week 35 are presented. |
| Change in Transferrin Saturation (TSAT): Week 4 | From baseline (mean of screening and day 1) to week 4 | Change from baseline in TSAT to week 4 is presented. |
| Change in TSAT: Mean of Weeks 10-12 | From baseline (mean of screening and day 1), week 10, week 12 | Change from baseline in TSAT to the mean of weeks 10-12 is presented. |
| Change in Reticulocyte Hemoglobin (CHr): Week 4 | From baseline (mean of screening and day 1) to week 4 | Change from baseline in CHr to week 4 is presented. |
| Basophils to Leukocytes Ratio: Week 12 | At week 12 | Basophils to leukocytes ratio at week 12 is presented. |
| Change in Hemoglobin From Screening to Peak Hemoglobin: Week 4 | From screening to week 4 | Change in hemoglobin from screening to peak hemoglobin at week 4 is presented. |
| Change in High Sensitivity C-reactive Protein (Hs-CRP): Mean of 10-12 Weeks | From baseline (mean of screening and day 1), week 10, week 12 | Change from baseline in hs-CRP to the mean of 10-12 weeks is presented. |
| Change in SAA: Mean of Weeks 10-12 | From baseline (mean of screening and day 1), week 10, week 12 | Change from baseline in SAA to the mean of weeks 10-12 is presented. |
| Change in Serum Pre-albumin: Mean of 10-12 Weeks | From baseline (mean of screening and day 1), week 10, week 12 | Change from baseline in serum pre-albumin to the mean of 10-12 weeks is presented. |
| Change in Albumin: Week 12 | From baseline (mean of screening and day 1) to week 12 | Change from baseline in albumin to week 12 is presented. |
| Change in Erythropoietin Resistance Index (ERI): Week 4 | From baseline (weekly mean of screening) to week 4 | Change from baseline in ERI to week 4 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL). |
| Change in ERI: Mean of Weeks 8-12 | From baseline (weekly mean of screening), week 8, week 12 | Change from baseline in ERI to the mean of weeks 8-12 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL). |
| Change in ERI: Mean of Weeks 10-12 | From baseline (weekly mean of screening), week 10, week 12 | Change from baseline in ERI to the mean of weeks 10-12 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL). |
| Change in CHr: Mean of Weeks 10-12 | From baseline (mean of screening and day 1), week 10, week 12 | Change from baseline in CHr to the mean of weeks 10-12 is presented. |
| Change in Hemoglobin: Week 4 | From baseline (mean of screening and day 1) to week 4 | Change from baseline in hemoglobin to week 4 is presented. |
| Change in Hemoglobin: Mean of Weeks 10-12 | From baseline (mean of screening and day 1), week 10, week 12 | Change from baseline in hemoglobin to weeks 10-12 is presented. |
| Change in Hemoglobin: Mean of Weeks 10-12, Excluding Hemoglobin Values Following a Change in the Total Weekly ESA Dose | From baseline (mean of screening and day 1), week 10, week 12 | Change from baseline in hemoglobin to weeks 10-12, excluding hemoglobin values following a change in the total weekly ESA (erythropoiesis stimulating agent) dose is presented. A change is defined as the first time when the ESA weekly dose goes up by \>25% or down by \>25% relative to the previous week's dose. |
| Change in ERI: Week 12 | From baseline (weekly mean of screening) to week 12 | Change from baseline in ERI to week 12 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL). |
| Change in ERI: Mean of Weeks 9-12 | From baseline (weekly mean of screening), week 9, week 12 | Change from baseline in ERI to the mean of weeks 9-12 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL). |
| Change in Hemoglobin: Week 12 | From baseline (mean of screening and day 1) to week 12 | Change from baseline in hemoglobin to week 12 is presented. |
| Change in Hemoglobin: Week 24 | From baseline (mean of screening and day 1) to week 24 | Change from baseline in hemoglobin to week 24 is presented. |
| Basophils: Week 12 | At week 12 | The observed values of basophils at week 12 are presented. |
| Basophils to Leukocytes Ratio: Week 24 | At week 24 | Basophils to leukocytes ratio at week 24 is presented. |
| Eosinophils: Week 12 | At week 12 | The observed values of eosinophils at week 12 are presented. |
| Eosinophils: Week 24 | At week 24 | The observed values of eosinophils at week 24 are presented. |
| Eosinophils to Leukocytes Ratio: Week 12 | At week 12 | Eosinophils to leukocytes ratio at week 12 is presented. |
| Eosinophils to Leukocytes Ratio: Week 24 | At week 24 | The eosinophils to leukocytes ratio at week 24 is presented. |
| Erythrocyte Mean Corpuscular Hemoglobin: Week 12 | At week 12 | The observed values of erythrocyte mean corpuscular hemoglobin at week 12 are presented. |
| Erythrocyte Mean Corpuscular Hemoglobin: Week 24 | At week 24 | The observed values of erythrocyte mean corpuscular hemoglobin at week 24 are presented. |
| Erythrocyte Mean Corpuscular Hemoglobin (HGB) Concentration: Week 12 | At week 12 | The observed values of erythrocyte mean corpuscular HGB concentration at week 12 are presented. |
| Erythrocyte Mean Corpuscular HGB Concentration: Week 24 | At week 24 | The observed values of erythrocyte mean corpuscular HGB concentration at week 24 are presented. |
| Erythrocyte Mean Corpuscular Volume: Week 12 | At week 12 | The observed values of erythrocyte mean corpuscular volume at week 12 are presented. |
| Erythrocyte Mean Corpuscular Volume: Week 24 | At week 24 | The observed values of erythrocyte mean corpuscular volume at week 24 are presented. |
| Erythrocytes: Week 12 | At week 12 | The observed values of erythrocytes at week 12 are presented. |
| Erythrocytes: Week 24 | At week 24 | The observed values of erythrocytes at week 24 are presented. |
| Hematocrit: Week 12 | At week 12 | The observed values of hematocrit at week 12 are presented. |
| Hematocrit: Week 24 | At week 24 | The observed values of hematocrit at week 24 are presented. |
| Hemoglobin: Week 12 | At week 12 | The observed values of hemoglobin at week 12 are presented. |
| Hemoglobin: Week 24 | At week 24 | The observed values of hemoglobin at week 24 are presented. |
| Hypochromatic Red Cells Week 12 | At week 12 | The observed values of hypochromatic red cells at week 12 are presented. |
| Hypochromatic Red Cells: Week 24 | At week 24 | The observed values of hypochromatic red cells at week 24 are presented. |
| Leukocytes: Week 12 | At week 12 | The observed values of leukocytes at week 12 are presented. |
| Leukocytes: Week 24 | At week 24 | The observed values of leukocytes at week 24 are presented. |
| Lymphocytes: Week 12 | At week 12 | The observed values of lymphocytes at week 12 are presented. |
| Lymphocytes: Week 24 | At week 24 | The observed values of lymphocytes at week 24 are presented. |
| Lymphocytes to Leukocytes Ratio: Week 12 | At week 12 | Lymphocytes to leukocytes ratio at week 12 is presented. |
| Lymphocytes to Leukocytes Ratio at Week 24 | At week 24 | Lymphocytes to leukocytes ratio at week 24 is presented. |
| Monocytes: Week 12 | At week 12 | The observed values of monocytes at week 12 are presented. |
| Monocytes: Week 24 | At week 24 | The observed values of monocytes at week 24 are presented. |
| Monocytes to Leukocytes Ratio: Week 12 | At week 12 | Monocytes to leukocytes ratio at week 12 is presented. |
| Monocytes to Leukocytes Ratio: Week 24 | At week 24 | Monocytes to leukocytes ratio at week 24 is presented. |
| Neutrophils: Week 12 | At week 12 | The observed values of neutrophils at week 12 are presented. |
| Neutrophils: Week 24 | At week 24 | The observed values of neutrophils at week 24 are presented. |
| Neutrophils to Leukocytes Ratio: Week 12 | At week 12 | Neutrophils to leukocytes ratio at week 12 is presented. |
| Neutrophils to Leukocytes Ratio: Week 24 | At week 24 | Neutrophils to leukocytes ratio at week 24 is presented. |
| Platelets: Week 12 | At week 12 | The observed values of platelets at week 12 are presented. |
| Platelets: Week 24 | At week 24 | The observed values of platelets at week 24 are presented. |
| Reticulocytes to Erythrocytes Ratio: Week 12 | At week 12 | Reticulocytes to erythrocytes ratio at week 12 is presented. |
| Reticulocytes to Erythrocytes Ratio: Week 24 | At week 24 | Reticulocytes to erythrocytes ratio at week 24 is presented. |
| Alanine Aminotransferase: Week 12 | At week 12 | The observed values of alanine aminotransferase at week 12 are presented. |
| Alanine Aminotransferase: Week 24 | At week 24 | The observed values of alanine aminotransferase at week 24 are presented. |
| Albumin: Week 12 | At week 12 | The observed values of albumin at week 12 are presented. |
| Albumin: Week 24 | At week 24 | The observed values of albumin at week 24 are presented. |
| Alkaline Phosphatase: Week 12 | At week 12 | The observed values of alkaline phosphatase at week 12 are presented. |
| Alkaline Phosphatase: Week 24 | At week 24 | The observed values of alkaline phosphatase at week 24 are presented. |
| Aspartate Aminotransferase: Week 12 | At week 12 | The observed values of aspartate aminotransferase at week 12 are presented. |
| Aspartate Aminotransferase: Week 24 | At week 24 | The observed values of aspartate aminotransferase at week 24 are presented. |
| Bicarbonate: Week 12 | At week 12 | The observed values of bicarbonate at week 12 are presented. |
| Bicarbonate: Week 24 | At week 24 | The observed values of bicarbonate at week 24 are presented. |
| Bilirubin: Week 12 | At week 12 | The observed values of bilirubin at week 12 are presented. |
| Bilirubin: Week 24 | At week 24 | The observed values of bilirubin at week 24 are presented. |
| Calcium: Week 12 | At week 12 | The observed values of calcium at week 12 are presented. |
| Calcium: Week 24 | At week 24 | The observed values of calcium at week 24 are presented. |
| Chloride: Week 12 | At week 12 | The observed values of chloride at week 12 are presented. |
| Chloride: Week 24 | At week 24 | The observed values of chloride at week 24 are presented. |
| Cholesterol: Week 12 | At week 12 | The observed values of cholesterol at week 12 are presented. |
| Cholesterol: Week 24 | At week 24 | The observed values of cholesterol at week 24 are presented. |
| Creatinine: Week 12 | At week 12 | The observed values of creatinine at week 12 are presented. |
| Creatinine: Week 24 | At week 24 | The observed values of creatinine at week 24 are presented. |
| Direct Bilirubin: Week 12 | At week 12 | The observed values of direct bilirubin at week 12 are presented. |
| Direct Bilirubin: Week 24 | At week 24 | The observed values of direct bilirubin at week 24 are presented. |
| Glucose: Week 12 | At week 12 | The observed values of glucose at week 12 are presented. |
| Glucose: Week 24 | At week 24 | The observed values of glucose at week 24 are presented. |
| High-density Lipoprotein (HDL) Cholesterol: Week 12 | At week 12 | The observed values of HDL cholesterol at week 12 are presented. |
| HDL Cholesterol: Week 24 | At week 24 | The observed values of HDL cholesterol at week 24 are presented. |
| Hepcidin-25: Week 12 | At week 12 | The observed values of hepcidin-25 at week 12 are presented. |
| Hepcidin-25: Week 24 | At week 24 | The observed values of hepcidin-25 at week 24 are presented. |
| Low-density Lipoproteins (LDL) Cholesterol: Week 12 | At week 12 | The observed values of LDL cholesterol at week 12 are presented. |
| LDL Cholesterol: Week 24 | At week 24 | The observed values of LDL cholesterol at week 24 are presented. |
| Lipoprotein-a: Week 12 | At week 12 | The observed values of lipoprotein-a at week 12 are presented. |
| Lipoprotein-a: Week 24 | At week 24 | The observed values of lipoprotein-a at week 24 are presented. |
| Phosphate: Week 12 | At week 12 | The observed values of phosphate at week 12 are presented. |
| Phosphate: Week 24 | At week 24 | The observed values of phosphate at week 24 are presented. |
| Potassium: Week 12 | At week 12 | The observed values of potassium at week 12 are presented. |
| Potassium: Week 24 | At week 24 | The observed values of potassium at week 24 are presented. |
| Sodium: Week 12 | At week 12 | The observed values of sodium at week 12 are presented. |
| Sodium: Week 24 | At week 24 | The observed values of sodium at week 24 are presented. |
| Triglycerides: Week 12 | At week 12 | The observed values of triglyceride at week 12 are presented. |
| Triglycerides: Week 24 | At week 24 | The observed values of triglycerides at week 24 are presented. |
| Urea Nitrogen: Week 12 | At week 12 | The observed values of urea nitrogen at week 12 are presented. |
| Urea Nitrogen: Week 24 | At week 24 | The observed values of urea nitrogen at week 24 are presented. |
| Pre-dialysis Body Mass Index (BMI): Week 12 | At week 12 | Pre-dialysis BMI values at week 12 are presented. |
| Pre-infusion BMI: Week 11 | At week 11 | Pre-infusion BMI values at week 11 are presented. |
| Pre-dialysis Diastolic Blood Pressure: Week 12 | At week 12 | Pre-dialysis diastolic blood pressure values at week 12 are presented. |
| Pre-dialysis Diastolic Blood Pressure: Week 24 | At week 24 | Pre-dialysis diastolic blood pressure values at week 24 are presented. |
| Pre-infusion Diastolic Blood Pressure: Week 11 | At week 11 | Pre-infusion diastolic blood pressure values at week 11 are presented. |
| Pre-dialysis Heart Rate: Week 12 | At week 12 | Pre-dialysis heart rate values at week 12 are presented. |
| Pre-dialysis Heart Rate: Week 24 | At week 24 | Pre-dialysis heart rate values at week 24 are presented. |
| Pre-infusion Heart Rate: Week 11 | At week 11 | Pre-infusion heart rate values at week 11 are presented. |
| Pre-dialysis Respiration Rate: Week 12 | At week 12 | Pre-dialysis respiration rate values at week 12 are presented. |
| Pre-dialysis Respiration Rate: Week 24 | At week 24 | Pre-dialysis respiration rate values at week 24 are presented. |
| Basophil: Week 24 | At week 24 | The observed values of basophils at week 24 are presented. |
| Pre-dialysis Systolic Blood Pressure: Week 12 | At week 12 | Pre-dialysis values of systolic blood pressure at week 12 are presented. |
| Pre-dialysis Systolic Blood Pressure: Week 24 | At week 24 | Pre-dialysis values of systolic blood pressure at week 24 are presented. |
| Pre-infusion Systolic Blood Pressure: Week 11 | At week 11 | Pre-infusion systolic blood pressure values at week 11 are presented. |
| Pre-dialysis Weight: Week 12 | At week 12 | Pre-dialysis weight values at week 12 are presented. |
| Pre-infusion Weight: Week 11 | At week 11 | Pre-infusion weight values at week 11 are presented. |
| Pre-dialysis Temperature: Week 12 | At week 12 | Pre-dialysis temperature values at week 12 are presented. |
| Pre-dialysis Temperature: Week 24 | At week 24 | Pre-dialysis temperature values at week 24 are presented. |
| Pre-infusion Temperature: Week 11 | At week 11 | Pre-infusion temperature values at week 11 are presented. |
| Area Under the Serum Concentration Time Curve From Time 0 to Infinity (AUC 0-α) of COR-001 | Week 1 (day 1, 3, and 5), Week 2 (day 8), Week 3 (day 15), Week 5 (day 29), Week 7 (day 43), Week 8 (day 50), Week 9 (day 57), Week 11 (day 71 and 75), Week 14 (day 92), Week 18 (day 120) and Week 35 (day 239). | Area under the serum concentration time curve from time 0 to infinity (AUC 0-α) of COR-001 is presented. |
| Elimination Half-life in the Initial Phase (t 1/2,α) | Week 1 (day 1, 3, and 5), Week 2 (day 8), Week 3 (day 15), Week 5 (day 29), Week 7 (day 43), Week 8 (day 50), Week 9 (day 57), Week 11 (day 71 and 75), Week 14 (day 92), Week 18 (day 120) and Week 35 (day 239). | Elimination half-life in the initial phase (t 1/2,α) is presented from week 0 to week 35. |
| Elimination Half-life in the Terminal Phase (t 1/2, z) | Week 1 (day 1, 3, and 5), Week 2 (day 8), Week 3 (day 15), Week 5 (day 29), Week 7 (day 43), Week 8 (day 50), Week 9 (day 57), Week 11 (day 71 and 75), Week 14 (day 92), Week 18 (day 120) and Week 35 (day 239). | Elimination half-life in the terminal phase(t 1/2, z) is presented from week 0 to week 35. |
| Maximum Serum Concentration (Cmax) | Week 1 (day 1, 3, and 5), Week 2 (day 8), Week 3 (day 15), Week 5 (day 29), Week 7 (day 43), Week 8 (day 50), Week 9 (day 57), Week 11 (day 71 and 75), Week 14 (day 92), Week 18 (day 120) and Week 35 (day 239). | Maximum serum concentration (Cmax) of COR-001 from week 0 to week 35 is presented. |
| Impact of ADAs on Pharmacokinetics | Week 1 (day 1, 3, and 5), Week 2 (day 8), Week 3 (day 15), Week 5 (day 29), Week 7 (day 43), Week 8 (day 50), Week 9 (day 57), Week 11 (day 71 and 75), Week 14 (day 92), Week 18 (day 120) and Week 35 (day 239). | Presence of ADA was a covariate for pharmacokinetics (PK) affecting V1 (volume of distribution for the central compartment). Impact of ADAs on V1 from baseline to week 35 is presented. In the below table, result presented is the bootstrap parameter estimate of the effect of ADA on V1 for a PK model that includes data for all arms combined. |
| Pre-infusion Respiration Rate: Week 11 | At week 11 | Pre-infusion respiration rate values at week 11 are presented. |
| Number of Adverse Events of Special Interest | Weeks 0-24 | Frequency of events of interest by treatment group and dose from baseline until the end of the safety follow-up period (week 24) were reported. Adverse events of special interest included severe infusion-related reactions, hypersensitivity reaction during study drug infusion, anaphylaxis and neutropenia events of grade 2 or higher (i.e., absolute neutrophil count \<1500/mm\^3 and decline by at least 25% from baseline). |
| Number of Treatment Emergent Adverse Events (TEAEs) | Week 0-24 | An AE (adverse event) is any undesirable event or any untoward medical occurrence that occurs to a participant during the course of a study, or the protocol-defined time after study termination, whether or not that event is considered Study Drug-related. A TEAE was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of study. Number of TEAEs from baseline until the end of safety follow up (week 24) were presented. |
Countries
United States
Participant flow
Recruitment details
The trial was conducted at 13 sites in the United States.
Pre-assignment details
Participants were randomized to ziltivekimab (COR-001) or placebo within each cohort. For the first and other higher dose cohorts, first 2 participants were randomized 1:1 to ziltivekimab or placebo, and were treated at least 48 hours prior to the remaining participants randomized in a 7:1 ratio of ziltivekimab to placebo. For cohorts with doses less than the maximum tolerated dose (MTD) determined from earlier cohorts, randomization was done in 8:2 ratio of ziltivekimab to placebo.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on Erythropoiesis stimulating agents (ESA) and parenteral iron, if being given. All the participants were hemodialysis patients. | 12 |
| COR-001 2 mg Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | 16 |
| COR-001 6 mg Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | 16 |
| COR-001 20 mg Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | 17 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 1 |
| Overall Study | Death | 0 | 0 | 1 | 1 |
| Overall Study | Missed dose | 0 | 0 | 0 | 3 |
Baseline characteristics
| Characteristic | Placebo | COR-001 2 mg | COR-001 6 mg | COR-001 20 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 62.8 Years STANDARD_DEVIATION 10.23 | 61.4 Years STANDARD_DEVIATION 12.95 | 63.8 Years STANDARD_DEVIATION 10.98 | 57.9 Years STANDARD_DEVIATION 10.56 | 61.3 Years STANDARD_DEVIATION 11.24 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 7 Participants | 3 Participants | 4 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 9 Participants | 13 Participants | 13 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 5 Participants | 10 Participants | 11 Participants | 31 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 10 Participants | 4 Participants | 5 Participants | 26 Participants |
| Sex: Female, Male Female | 3 Participants | 9 Participants | 8 Participants | 9 Participants | 29 Participants |
| Sex: Female, Male Male | 9 Participants | 7 Participants | 8 Participants | 8 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 16 | 2 / 16 | 2 / 17 |
| other Total, other adverse events | 7 / 12 | 11 / 16 | 15 / 16 | 10 / 17 |
| serious Total, serious adverse events | 3 / 12 | 4 / 16 | 7 / 16 | 6 / 17 |
Outcome results
Primary
Change in High-sensitivity C-reactive Protein (hsCRP): Week 4
Change from the baseline in hsCRP values to week 4 are presented.
Time frame: From baseline (mean of screening and day 1) to week 4
Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in High-sensitivity C-reactive Protein (hsCRP): Week 4 | 0.373 Milligrams per liter (mg/L) | Standard Deviation 3.765 |
| COR-001 2 mg | Change in High-sensitivity C-reactive Protein (hsCRP): Week 4 | -10.383 Milligrams per liter (mg/L) | Standard Deviation 10.395 |
| COR-001 6 mg | Change in High-sensitivity C-reactive Protein (hsCRP): Week 4 | -11.981 Milligrams per liter (mg/L) | Standard Deviation 8.232 |
| COR-001 20 mg | Change in High-sensitivity C-reactive Protein (hsCRP): Week 4 | -14.561 Milligrams per liter (mg/L) | Standard Deviation 11.836 |
Comparison: The P-value was obtained from rank transformed analysis of covariance (ANCOVA) model, where the rank transformed change from baseline (CFB) values as the response variable and treatments as a factor and the rank transformed baseline value as its covariate.p-value: 0.00295% CI: [-9.082, -2.25]ANCOVA
Comparison: The P-value was obtained from rank transformed analysis of covariance (ANCOVA) model, where the rank transformed change from baseline (CFB) values as the response variable and treatments as a factor and the rank transformed baseline value as its covariate.p-value: <0.00195% CI: [-10.613, -3.214]ANCOVA
Comparison: The P-value was obtained from rank transformed analysis of covariance (ANCOVA) model, where the rank transformed change from baseline (CFB) values as the response variable and treatments as a factor and the rank transformed baseline value as its covariate.p-value: <0.00195% CI: [-13.217, -5.965]ANCOVA
Primary
Change in Serum Amyloid A (SAA): Week 4
Change from the baseline in serum amyloid A (SAA) values to week 4 are presented.
Time frame: From baseline (mean of screening and day 1) to week 4
Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Serum Amyloid A (SAA): Week 4 | -3.733 mg/L | Standard Deviation 6.955 |
| COR-001 2 mg | Change in Serum Amyloid A (SAA): Week 4 | -22.056 mg/L | Standard Deviation 37.914 |
| COR-001 6 mg | Change in Serum Amyloid A (SAA): Week 4 | -9.878 mg/L | Standard Deviation 6.687 |
| COR-001 20 mg | Change in Serum Amyloid A (SAA): Week 4 | -31.910 mg/L | Standard Deviation 41.502 |
Primary
Characterization of Maximum Tolerated Dose (MTD)
The MTD assessment was based on safety data. If more than 2 of 8 active participants in a cohort experience a Dose-Limiting Toxicities (DLT), the MTD was considered to have been exceeded. The DLT threshold was defined using a threshold of greater than or equal to (\>=) Grade 3 events, which includes severe: infusion-related reactions, cardiopulmonary infusion reactions, anaphylaxis, or hypersensitivity. DLTs are defined as follows: 1. Confirmed Grade 3 neutropenia and representing a decline of \> 25% from baseline 2. Serious adverse events (SAEs) of infection in the presence of confirmed Grade 2 or higher new onset lymphopenia or new onset neutropenia. 3. ≥ Grade 3 ALT (Alanine transaminase) or AST(Aspartate transaminase) 4. ≥ Grade 4 hematologic toxicity 5. ≥ Grade 3 non-hematologic toxicity
Time frame: Weeks 0-24
Population: The MTD analysis population included all participants in the safety analysis population, which included all participants randomized and treated with any amount of study medication with exception of those replaced due to a non-safety reason.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Characterization of Maximum Tolerated Dose (MTD) | >= Grade 3 non-hematologic toxicity | 0 Events |
| Placebo | Characterization of Maximum Tolerated Dose (MTD) | >= Grade 3 ALT or AST | 0 Events |
| Placebo | Characterization of Maximum Tolerated Dose (MTD) | Confirmed Grade 3 neutropenia and representing a decline of > 25% from baseline | 0 Events |
| Placebo | Characterization of Maximum Tolerated Dose (MTD) | >= Grade 4 hematologic toxicity | 0 Events |
| Placebo | Characterization of Maximum Tolerated Dose (MTD) | Infection SAEs with confirmed Grade 2 or higher new onset lymphopenia or new onset neutropenia. | 0 Events |
| COR-001 2 mg | Characterization of Maximum Tolerated Dose (MTD) | >= Grade 4 hematologic toxicity | 0 Events |
| COR-001 2 mg | Characterization of Maximum Tolerated Dose (MTD) | >= Grade 3 non-hematologic toxicity | 0 Events |
| COR-001 2 mg | Characterization of Maximum Tolerated Dose (MTD) | Confirmed Grade 3 neutropenia and representing a decline of > 25% from baseline | 0 Events |
| COR-001 2 mg | Characterization of Maximum Tolerated Dose (MTD) | >= Grade 3 ALT or AST | 0 Events |
| COR-001 2 mg | Characterization of Maximum Tolerated Dose (MTD) | Infection SAEs with confirmed Grade 2 or higher new onset lymphopenia or new onset neutropenia. | 0 Events |
| COR-001 6 mg | Characterization of Maximum Tolerated Dose (MTD) | >= Grade 4 hematologic toxicity | 0 Events |
| COR-001 6 mg | Characterization of Maximum Tolerated Dose (MTD) | Infection SAEs with confirmed Grade 2 or higher new onset lymphopenia or new onset neutropenia. | 0 Events |
| COR-001 6 mg | Characterization of Maximum Tolerated Dose (MTD) | >= Grade 3 ALT or AST | 0 Events |
| COR-001 6 mg | Characterization of Maximum Tolerated Dose (MTD) | >= Grade 3 non-hematologic toxicity | 0 Events |
| COR-001 6 mg | Characterization of Maximum Tolerated Dose (MTD) | Confirmed Grade 3 neutropenia and representing a decline of > 25% from baseline | 0 Events |
| COR-001 20 mg | Characterization of Maximum Tolerated Dose (MTD) | >= Grade 3 non-hematologic toxicity | 0 Events |
| COR-001 20 mg | Characterization of Maximum Tolerated Dose (MTD) | >= Grade 3 ALT or AST | 0 Events |
| COR-001 20 mg | Characterization of Maximum Tolerated Dose (MTD) | Infection SAEs with confirmed Grade 2 or higher new onset lymphopenia or new onset neutropenia. | 0 Events |
| COR-001 20 mg | Characterization of Maximum Tolerated Dose (MTD) | >= Grade 4 hematologic toxicity | 0 Events |
| COR-001 20 mg | Characterization of Maximum Tolerated Dose (MTD) | Confirmed Grade 3 neutropenia and representing a decline of > 25% from baseline | 0 Events |
Secondary
Alanine Aminotransferase: Week 12
The observed values of alanine aminotransferase at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Alanine Aminotransferase: Week 12 | 12.1 units per liter (U/L) | Standard Deviation 6.61 |
| COR-001 2 mg | Alanine Aminotransferase: Week 12 | 18.6 units per liter (U/L) | Standard Deviation 13.85 |
| COR-001 6 mg | Alanine Aminotransferase: Week 12 | 19.9 units per liter (U/L) | Standard Deviation 10.89 |
| COR-001 20 mg | Alanine Aminotransferase: Week 12 | 19.0 units per liter (U/L) | Standard Deviation 9.43 |
Secondary
Alanine Aminotransferase: Week 24
The observed values of alanine aminotransferase at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Alanine Aminotransferase: Week 24 | 8.7 U/L | Standard Deviation 4.67 |
| COR-001 2 mg | Alanine Aminotransferase: Week 24 | 11.9 U/L | Standard Deviation 4.78 |
| COR-001 6 mg | Alanine Aminotransferase: Week 24 | 15.3 U/L | Standard Deviation 6.81 |
| COR-001 20 mg | Alanine Aminotransferase: Week 24 | 15.4 U/L | Standard Deviation 6.35 |
Secondary
Albumin: Week 12
The observed values of albumin at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Albumin: Week 12 | 3.96 g/dL | Standard Deviation 0.382 |
| COR-001 2 mg | Albumin: Week 12 | 3.90 g/dL | Standard Deviation 0.21 |
| COR-001 6 mg | Albumin: Week 12 | 3.97 g/dL | Standard Deviation 0.304 |
| COR-001 20 mg | Albumin: Week 12 | 3.98 g/dL | Standard Deviation 0.273 |
Secondary
Albumin: Week 24
The observed values of albumin at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Albumin: Week 24 | 3.75 g/dL | Standard Deviation 0.432 |
| COR-001 2 mg | Albumin: Week 24 | 3.83 g/dL | Standard Deviation 0.305 |
| COR-001 6 mg | Albumin: Week 24 | 3.77 g/dL | Standard Deviation 0.347 |
| COR-001 20 mg | Albumin: Week 24 | 3.84 g/dL | Standard Deviation 0.456 |
Secondary
Alkaline Phosphatase: Week 12
The observed values of alkaline phosphatase at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Alkaline Phosphatase: Week 12 | 103.0 U/L | Standard Deviation 56.43 |
| COR-001 2 mg | Alkaline Phosphatase: Week 12 | 125.4 U/L | Standard Deviation 87.32 |
| COR-001 6 mg | Alkaline Phosphatase: Week 12 | 107.5 U/L | Standard Deviation 57.54 |
| COR-001 20 mg | Alkaline Phosphatase: Week 12 | 106.2 U/L | Standard Deviation 44.69 |
Secondary
Alkaline Phosphatase: Week 24
The observed values of alkaline phosphatase at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Alkaline Phosphatase: Week 24 | 99.8 U/L | Standard Deviation 51.17 |
| COR-001 2 mg | Alkaline Phosphatase: Week 24 | 140.6 U/L | Standard Deviation 119.26 |
| COR-001 6 mg | Alkaline Phosphatase: Week 24 | 121.2 U/L | Standard Deviation 55.26 |
| COR-001 20 mg | Alkaline Phosphatase: Week 24 | 95.2 U/L | Standard Deviation 53.01 |
Secondary
Area Under the Serum Concentration Time Curve From Time 0 to Infinity (AUC 0-α) of COR-001
Area under the serum concentration time curve from time 0 to infinity (AUC 0-α) of COR-001 is presented.
Time frame: Week 1 (day 1, 3, and 5), Week 2 (day 8), Week 3 (day 15), Week 5 (day 29), Week 7 (day 43), Week 8 (day 50), Week 9 (day 57), Week 11 (day 71 and 75), Week 14 (day 92), Week 18 (day 120) and Week 35 (day 239).
Population: The PK population included all participants who had any valid samples measured for study drug levels. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Area Under the Serum Concentration Time Curve From Time 0 to Infinity (AUC 0-α) of COR-001 | 11962 nanogram*day/milliliter (ng*day/mL) | Standard Deviation 4731 |
| COR-001 2 mg | Area Under the Serum Concentration Time Curve From Time 0 to Infinity (AUC 0-α) of COR-001 | 40911 nanogram*day/milliliter (ng*day/mL) | Standard Deviation 23629 |
| COR-001 6 mg | Area Under the Serum Concentration Time Curve From Time 0 to Infinity (AUC 0-α) of COR-001 | 118177 nanogram*day/milliliter (ng*day/mL) | Standard Deviation 60393 |
Secondary
Aspartate Aminotransferase: Week 12
The observed values of aspartate aminotransferase at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Aspartate Aminotransferase: Week 12 | 15.5 U/L | Standard Deviation 5.89 |
| COR-001 2 mg | Aspartate Aminotransferase: Week 12 | 18.1 U/L | Standard Deviation 11.57 |
| COR-001 6 mg | Aspartate Aminotransferase: Week 12 | 20.5 U/L | Standard Deviation 10.85 |
| COR-001 20 mg | Aspartate Aminotransferase: Week 12 | 15.7 U/L | Standard Deviation 4.61 |
Secondary
Aspartate Aminotransferase: Week 24
The observed values of aspartate aminotransferase at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Aspartate Aminotransferase: Week 24 | 14.7 U/L | Standard Deviation 5.57 |
| COR-001 2 mg | Aspartate Aminotransferase: Week 24 | 14.3 U/L | Standard Deviation 5.59 |
| COR-001 6 mg | Aspartate Aminotransferase: Week 24 | 17.3 U/L | Standard Deviation 7.75 |
| COR-001 20 mg | Aspartate Aminotransferase: Week 24 | 14.7 U/L | Standard Deviation 3.2 |
Secondary
Basophils to Leukocytes Ratio: Week 12
Basophils to leukocytes ratio at week 12 is presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Basophils to Leukocytes Ratio: Week 12 | 0.65 Ratio of basophils to leukocytes | Standard Deviation 0.458 |
| COR-001 2 mg | Basophils to Leukocytes Ratio: Week 12 | 0.45 Ratio of basophils to leukocytes | Standard Deviation 0.553 |
| COR-001 6 mg | Basophils to Leukocytes Ratio: Week 12 | 0.95 Ratio of basophils to leukocytes | Standard Deviation 0.447 |
| COR-001 20 mg | Basophils to Leukocytes Ratio: Week 12 | 0.87 Ratio of basophils to leukocytes | Standard Deviation 0.954 |
Secondary
Basophils to Leukocytes Ratio: Week 24
Basophils to leukocytes ratio at week 24 is presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Basophils to Leukocytes Ratio: Week 24 | 0.62 Ratio of basophils to leukocytes | Standard Deviation 0.458 |
| COR-001 2 mg | Basophils to Leukocytes Ratio: Week 24 | 0.83 Ratio of basophils to leukocytes | Standard Deviation 0.722 |
| COR-001 6 mg | Basophils to Leukocytes Ratio: Week 24 | 1.29 Ratio of basophils to leukocytes | Standard Deviation 1.296 |
| COR-001 20 mg | Basophils to Leukocytes Ratio: Week 24 | 0.57 Ratio of basophils to leukocytes | Standard Deviation 0.521 |
Secondary
Basophils: Week 12
The observed values of basophils at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Basophils: Week 12 | 0.03 10^3 cells per microliter(10^3 cells/uL) | Standard Deviation 0.048 |
| COR-001 2 mg | Basophils: Week 12 | 0.02 10^3 cells per microliter(10^3 cells/uL) | Standard Deviation 0.041 |
| COR-001 6 mg | Basophils: Week 12 | 0.04 10^3 cells per microliter(10^3 cells/uL) | Standard Deviation 0.051 |
| COR-001 20 mg | Basophils: Week 12 | 0.03 10^3 cells per microliter(10^3 cells/uL) | Standard Deviation 0.062 |
Secondary
Basophil: Week 24
The observed values of basophils at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Basophil: Week 24 | 0.05 10^3 cells/uL | Standard Deviation 0.052 |
| COR-001 2 mg | Basophil: Week 24 | 0.04 10^3 cells/uL | Standard Deviation 0.062 |
| COR-001 6 mg | Basophil: Week 24 | 0.08 10^3 cells/uL | Standard Deviation 0.083 |
| COR-001 20 mg | Basophil: Week 24 | 0.02 10^3 cells/uL | Standard Deviation 0.042 |
Secondary
Bicarbonate: Week 12
The observed values of bicarbonate at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Bicarbonate: Week 12 | 23.5 millimoles per liter (mmol/L) | Standard Deviation 3.06 |
| COR-001 2 mg | Bicarbonate: Week 12 | 23.1 millimoles per liter (mmol/L) | Standard Deviation 3.03 |
| COR-001 6 mg | Bicarbonate: Week 12 | 22.7 millimoles per liter (mmol/L) | Standard Deviation 3.26 |
| COR-001 20 mg | Bicarbonate: Week 12 | 25.5 millimoles per liter (mmol/L) | Standard Deviation 3.5 |
Secondary
Bicarbonate: Week 24
The observed values of bicarbonate at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Bicarbonate: Week 24 | 23.3 mmol/L | Standard Deviation 3 |
| COR-001 2 mg | Bicarbonate: Week 24 | 24.6 mmol/L | Standard Deviation 2.83 |
| COR-001 6 mg | Bicarbonate: Week 24 | 22.4 mmol/L | Standard Deviation 2.43 |
| COR-001 20 mg | Bicarbonate: Week 24 | 26.0 mmol/L | Standard Deviation 3.28 |
Secondary
Bilirubin: Week 12
The observed values of bilirubin at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Bilirubin: Week 12 | 0.490 mg/dL | Standard Deviation 0.186 |
| COR-001 2 mg | Bilirubin: Week 12 | 0.450 mg/dL | Standard Deviation 0.157 |
| COR-001 6 mg | Bilirubin: Week 12 | 0.603 mg/dL | Standard Deviation 0.234 |
| COR-001 20 mg | Bilirubin: Week 12 | 0.553 mg/dL | Standard Deviation 0.15 |
Secondary
Bilirubin: Week 24
The observed values of bilirubin at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Bilirubin: Week 24 | 0.450 mg/dL | Standard Deviation 0.169 |
| COR-001 2 mg | Bilirubin: Week 24 | 0.430 mg/dL | Standard Deviation 0.142 |
| COR-001 6 mg | Bilirubin: Week 24 | 0.565 mg/dL | Standard Deviation 0.184 |
| COR-001 20 mg | Bilirubin: Week 24 | 0.520 mg/dL | Standard Deviation 0.125 |
Secondary
Calcium: Week 12
The observed values of calcium at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Calcium: Week 12 | 8.89 mg/dL | Standard Deviation 0.883 |
| COR-001 2 mg | Calcium: Week 12 | 8.54 mg/dL | Standard Deviation 0.737 |
| COR-001 6 mg | Calcium: Week 12 | 8.90 mg/dL | Standard Deviation 0.777 |
| COR-001 20 mg | Calcium: Week 12 | 8.39 mg/dL | Standard Deviation 0.727 |
Secondary
Calcium: Week 24
The observed values of calcium at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Calcium: Week 24 | 8.73 mg/dL | Standard Deviation 0.74 |
| COR-001 2 mg | Calcium: Week 24 | 8.95 mg/dL | Standard Deviation 0.734 |
| COR-001 6 mg | Calcium: Week 24 | 8.76 mg/dL | Standard Deviation 0.653 |
| COR-001 20 mg | Calcium: Week 24 | 8.82 mg/dL | Standard Deviation 1.011 |
Secondary
Change in Albumin: Week 12
Change from baseline in albumin to week 12 is presented.
Time frame: From baseline (mean of screening and day 1) to week 12
Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Albumin: Week 12 | 0.042 Grams per decilitre (g/dL) | Standard Deviation 0.288 |
| COR-001 2 mg | Change in Albumin: Week 12 | 0.122 Grams per decilitre (g/dL) | Standard Deviation 0.212 |
| COR-001 6 mg | Change in Albumin: Week 12 | 0.192 Grams per decilitre (g/dL) | Standard Deviation 0.151 |
| COR-001 20 mg | Change in Albumin: Week 12 | 0.336 Grams per decilitre (g/dL) | Standard Deviation 0.192 |
Secondary
Change in CHr: Mean of Weeks 10-12
Change from baseline in CHr to the mean of weeks 10-12 is presented.
Time frame: From baseline (mean of screening and day 1), week 10, week 12
Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in CHr: Mean of Weeks 10-12 | -0.035 pg | Standard Deviation 1.264 |
| COR-001 2 mg | Change in CHr: Mean of Weeks 10-12 | 0.859 pg | Standard Deviation 1.098 |
| COR-001 6 mg | Change in CHr: Mean of Weeks 10-12 | 1.271 pg | Standard Deviation 1.264 |
| COR-001 20 mg | Change in CHr: Mean of Weeks 10-12 | 1.143 pg | Standard Deviation 1.635 |
Secondary
Change in ERI: Mean of Weeks 10-12
Change from baseline in ERI to the mean of weeks 10-12 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL).
Time frame: From baseline (weekly mean of screening), week 10, week 12
Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in ERI: Mean of Weeks 10-12 | -2.112 (Units/kg/week) per (g/dL) | Standard Deviation 11.476 |
| COR-001 2 mg | Change in ERI: Mean of Weeks 10-12 | -6.477 (Units/kg/week) per (g/dL) | Standard Deviation 8.756 |
| COR-001 6 mg | Change in ERI: Mean of Weeks 10-12 | -8.272 (Units/kg/week) per (g/dL) | Standard Deviation 8.77 |
| COR-001 20 mg | Change in ERI: Mean of Weeks 10-12 | -8.690 (Units/kg/week) per (g/dL) | Standard Deviation 6.005 |
Secondary
Change in ERI: Mean of Weeks 8-12
Change from baseline in ERI to the mean of weeks 8-12 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL).
Time frame: From baseline (weekly mean of screening), week 8, week 12
Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in ERI: Mean of Weeks 8-12 | -2.714 (Units/kg/week) per (g/dL) | Standard Deviation 10.546 |
| COR-001 2 mg | Change in ERI: Mean of Weeks 8-12 | -5.689 (Units/kg/week) per (g/dL) | Standard Deviation 7.824 |
| COR-001 6 mg | Change in ERI: Mean of Weeks 8-12 | -7.842 (Units/kg/week) per (g/dL) | Standard Deviation 8.231 |
| COR-001 20 mg | Change in ERI: Mean of Weeks 8-12 | -8.787 (Units/kg/week) per (g/dL) | Standard Deviation 5.952 |
Secondary
Change in ERI: Mean of Weeks 9-12
Change from baseline in ERI to the mean of weeks 9-12 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL).
Time frame: From baseline (weekly mean of screening), week 9, week 12
Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in ERI: Mean of Weeks 9-12 | -2.320 (Units/kg/week) per (g/dL) | Standard Deviation 11.392 |
| COR-001 2 mg | Change in ERI: Mean of Weeks 9-12 | -6.338 (Units/kg/week) per (g/dL) | Standard Deviation 8.87 |
| COR-001 6 mg | Change in ERI: Mean of Weeks 9-12 | -8.293 (Units/kg/week) per (g/dL) | Standard Deviation 8.78 |
| COR-001 20 mg | Change in ERI: Mean of Weeks 9-12 | -8.756 (Units/kg/week) per (g/dL) | Standard Deviation 5.949 |
Secondary
Change in ERI: Week 12
Change from baseline in ERI to week 12 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL).
Time frame: From baseline (weekly mean of screening) to week 12
Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in ERI: Week 12 | -3.229 (Units/kg/week) per (g/dL) | Standard Deviation 12.084 |
| COR-001 2 mg | Change in ERI: Week 12 | -6.381 (Units/kg/week) per (g/dL) | Standard Deviation 8.956 |
| COR-001 6 mg | Change in ERI: Week 12 | -8.835 (Units/kg/week) per (g/dL) | Standard Deviation 8.785 |
| COR-001 20 mg | Change in ERI: Week 12 | -8.690 (Units/kg/week) per (g/dL) | Standard Deviation 6.356 |
Secondary
Change in Erythropoietin Resistance Index (ERI): Week 4
Change from baseline in ERI to week 4 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL).
Time frame: From baseline (weekly mean of screening) to week 4
Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Erythropoietin Resistance Index (ERI): Week 4 | -1.444 (Unit/kg/week) per (g/dL) | Standard Deviation 3.59 |
| COR-001 2 mg | Change in Erythropoietin Resistance Index (ERI): Week 4 | -0.975 (Unit/kg/week) per (g/dL) | Standard Deviation 1.716 |
| COR-001 6 mg | Change in Erythropoietin Resistance Index (ERI): Week 4 | -3.175 (Unit/kg/week) per (g/dL) | Standard Deviation 4.761 |
| COR-001 20 mg | Change in Erythropoietin Resistance Index (ERI): Week 4 | -4.211 (Unit/kg/week) per (g/dL) | Standard Deviation 5.785 |
Secondary
Change in Hemoglobin From Screening to Peak Hemoglobin: Week 4
Change in hemoglobin from screening to peak hemoglobin at week 4 is presented.
Time frame: From screening to week 4
Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Hemoglobin From Screening to Peak Hemoglobin: Week 4 | -0.043 g/dL | Standard Deviation 1.416 |
| COR-001 2 mg | Change in Hemoglobin From Screening to Peak Hemoglobin: Week 4 | 0.473 g/dL | Standard Deviation 0.751 |
| COR-001 6 mg | Change in Hemoglobin From Screening to Peak Hemoglobin: Week 4 | 0.805 g/dL | Standard Deviation 0.957 |
| COR-001 20 mg | Change in Hemoglobin From Screening to Peak Hemoglobin: Week 4 | 0.973 g/dL | Standard Deviation 0.72 |
Secondary
Change in Hemoglobin: Mean of Weeks 10-12
Change from baseline in hemoglobin to weeks 10-12 is presented.
Time frame: From baseline (mean of screening and day 1), week 10, week 12
Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Hemoglobin: Mean of Weeks 10-12 | -0.107 g/dL | Standard Deviation 1.756 |
| COR-001 2 mg | Change in Hemoglobin: Mean of Weeks 10-12 | 0.848 g/dL | Standard Deviation 1.156 |
| COR-001 6 mg | Change in Hemoglobin: Mean of Weeks 10-12 | 0.963 g/dL | Standard Deviation 1.131 |
| COR-001 20 mg | Change in Hemoglobin: Mean of Weeks 10-12 | 0.772 g/dL | Standard Deviation 1.236 |
Secondary
Change in Hemoglobin: Mean of Weeks 10-12, Excluding Hemoglobin Values Following a Change in the Total Weekly ESA Dose
Change from baseline in hemoglobin to weeks 10-12, excluding hemoglobin values following a change in the total weekly ESA (erythropoiesis stimulating agent) dose is presented. A change is defined as the first time when the ESA weekly dose goes up by \>25% or down by \>25% relative to the previous week's dose.
Time frame: From baseline (mean of screening and day 1), week 10, week 12
Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Hemoglobin: Mean of Weeks 10-12, Excluding Hemoglobin Values Following a Change in the Total Weekly ESA Dose | 0.352 g/dL | Standard Deviation 1.225 |
| COR-001 2 mg | Change in Hemoglobin: Mean of Weeks 10-12, Excluding Hemoglobin Values Following a Change in the Total Weekly ESA Dose | 0.228 g/dL | Standard Deviation 0.506 |
| COR-001 6 mg | Change in Hemoglobin: Mean of Weeks 10-12, Excluding Hemoglobin Values Following a Change in the Total Weekly ESA Dose | 0.627 g/dL | Standard Deviation 0.988 |
| COR-001 20 mg | Change in Hemoglobin: Mean of Weeks 10-12, Excluding Hemoglobin Values Following a Change in the Total Weekly ESA Dose | 0.567 g/dL | Standard Deviation 1.226 |
Secondary
Change in Hemoglobin: Week 12
Change from baseline in hemoglobin to week 12 is presented.
Time frame: From baseline (mean of screening and day 1) to week 12
Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Hemoglobin: Week 12 | 0.130 g/dL | Standard Deviation 1.24 |
| COR-001 2 mg | Change in Hemoglobin: Week 12 | 0.502 g/dL | Standard Deviation 1.029 |
| COR-001 6 mg | Change in Hemoglobin: Week 12 | 0.806 g/dL | Standard Deviation 1.234 |
| COR-001 20 mg | Change in Hemoglobin: Week 12 | 0.755 g/dL | Standard Deviation 1.379 |
Secondary
Change in Hemoglobin: Week 24
Change from baseline in hemoglobin to week 24 is presented.
Time frame: From baseline (mean of screening and day 1) to week 24
Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Hemoglobin: Week 24 | -0.803 g/dL | Standard Deviation 1.929 |
| COR-001 2 mg | Change in Hemoglobin: Week 24 | 0.154 g/dL | Standard Deviation 1.083 |
| COR-001 6 mg | Change in Hemoglobin: Week 24 | -0.267 g/dL | Standard Deviation 0.826 |
| COR-001 20 mg | Change in Hemoglobin: Week 24 | -0.079 g/dL | Standard Deviation 0.703 |
Secondary
Change in Hemoglobin: Week 4
Change from baseline in hemoglobin to week 4 is presented.
Time frame: From baseline (mean of screening and day 1) to week 4
Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Hemoglobin: Week 4 | -0.043 g/dL | Standard Deviation 1.416 |
| COR-001 2 mg | Change in Hemoglobin: Week 4 | 0.473 g/dL | Standard Deviation 0.751 |
| COR-001 6 mg | Change in Hemoglobin: Week 4 | 0.805 g/dL | Standard Deviation 0.957 |
| COR-001 20 mg | Change in Hemoglobin: Week 4 | 0.973 g/dL | Standard Deviation 0.72 |
Secondary
Change in High Sensitivity C-reactive Protein (Hs-CRP): Mean of 10-12 Weeks
Change from baseline in hs-CRP to the mean of 10-12 weeks is presented.
Time frame: From baseline (mean of screening and day 1), week 10, week 12
Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in High Sensitivity C-reactive Protein (Hs-CRP): Mean of 10-12 Weeks | -0.021 mg/L | Standard Deviation 0.293 |
| COR-001 2 mg | Change in High Sensitivity C-reactive Protein (Hs-CRP): Mean of 10-12 Weeks | -0.534 mg/L | Standard Deviation 0.439 |
| COR-001 6 mg | Change in High Sensitivity C-reactive Protein (Hs-CRP): Mean of 10-12 Weeks | -0.916 mg/L | Standard Deviation 0.337 |
| COR-001 20 mg | Change in High Sensitivity C-reactive Protein (Hs-CRP): Mean of 10-12 Weeks | -1.462 mg/L | Standard Deviation 0.554 |
Secondary
Change in Reticulocyte Hemoglobin (CHr): Week 4
Change from baseline in CHr to week 4 is presented.
Time frame: From baseline (mean of screening and day 1) to week 4
Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Reticulocyte Hemoglobin (CHr): Week 4 | -0.265 Picograms (pg) | Standard Deviation 1.216 |
| COR-001 2 mg | Change in Reticulocyte Hemoglobin (CHr): Week 4 | 1.197 Picograms (pg) | Standard Deviation 1.183 |
| COR-001 6 mg | Change in Reticulocyte Hemoglobin (CHr): Week 4 | 1.188 Picograms (pg) | Standard Deviation 1.09 |
| COR-001 20 mg | Change in Reticulocyte Hemoglobin (CHr): Week 4 | 0.286 Picograms (pg) | Standard Deviation 2.265 |
Secondary
Change in SAA: Mean of Weeks 10-12
Change from baseline in SAA to the mean of weeks 10-12 is presented.
Time frame: From baseline (mean of screening and day 1), week 10, week 12
Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in SAA: Mean of Weeks 10-12 | -1.262 mg/L | Standard Deviation 19.056 |
| COR-001 2 mg | Change in SAA: Mean of Weeks 10-12 | -24.323 mg/L | Standard Deviation 41.375 |
| COR-001 6 mg | Change in SAA: Mean of Weeks 10-12 | -8.688 mg/L | Standard Deviation 6.665 |
| COR-001 20 mg | Change in SAA: Mean of Weeks 10-12 | -30.324 mg/L | Standard Deviation 37.812 |
Secondary
Change in Serum Pre-albumin: Mean of 10-12 Weeks
Change from baseline in serum pre-albumin to the mean of 10-12 weeks is presented.
Time frame: From baseline (mean of screening and day 1), week 10, week 12
Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Serum Pre-albumin: Mean of 10-12 Weeks | 0.273 Milligrams per decilitre (mg/dL) | Standard Deviation 5.716 |
| COR-001 2 mg | Change in Serum Pre-albumin: Mean of 10-12 Weeks | 6.032 Milligrams per decilitre (mg/dL) | Standard Deviation 6.989 |
| COR-001 6 mg | Change in Serum Pre-albumin: Mean of 10-12 Weeks | 8.571 Milligrams per decilitre (mg/dL) | Standard Deviation 5.362 |
| COR-001 20 mg | Change in Serum Pre-albumin: Mean of 10-12 Weeks | 11.170 Milligrams per decilitre (mg/dL) | Standard Deviation 4.983 |
Secondary
Change in Transferrin Saturation (TSAT): Week 4
Change from baseline in TSAT to week 4 is presented.
Time frame: From baseline (mean of screening and day 1) to week 4
Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Transferrin Saturation (TSAT): Week 4 | 0.467 Percentage of TSAT | Standard Deviation 6.733 |
| COR-001 2 mg | Change in Transferrin Saturation (TSAT): Week 4 | 5.622 Percentage of TSAT | Standard Deviation 12.942 |
| COR-001 6 mg | Change in Transferrin Saturation (TSAT): Week 4 | 1.806 Percentage of TSAT | Standard Deviation 11.197 |
| COR-001 20 mg | Change in Transferrin Saturation (TSAT): Week 4 | 15.778 Percentage of TSAT | Standard Deviation 12.384 |
Secondary
Change in TSAT: Mean of Weeks 10-12
Change from baseline in TSAT to the mean of weeks 10-12 is presented.
Time frame: From baseline (mean of screening and day 1), week 10, week 12
Population: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in TSAT: Mean of Weeks 10-12 | 2.278 Percentage of TSAT | Standard Deviation 8.093 |
| COR-001 2 mg | Change in TSAT: Mean of Weeks 10-12 | 6.417 Percentage of TSAT | Standard Deviation 7.157 |
| COR-001 6 mg | Change in TSAT: Mean of Weeks 10-12 | 9.167 Percentage of TSAT | Standard Deviation 8.569 |
| COR-001 20 mg | Change in TSAT: Mean of Weeks 10-12 | 9.028 Percentage of TSAT | Standard Deviation 6.121 |
Secondary
Chloride: Week 12
The observed values of chloride at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Chloride: Week 12 | 97.0 mmol/L | Standard Deviation 3.69 |
| COR-001 2 mg | Chloride: Week 12 | 98.6 mmol/L | Standard Deviation 5.34 |
| COR-001 6 mg | Chloride: Week 12 | 98.0 mmol/L | Standard Deviation 4.87 |
| COR-001 20 mg | Chloride: Week 12 | 98.5 mmol/L | Standard Deviation 2.47 |
Secondary
Chloride: Week 24
The observed values of chloride at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Chloride: Week 24 | 98.5 mmol/L | Standard Deviation 3.67 |
| COR-001 2 mg | Chloride: Week 24 | 97.7 mmol/L | Standard Deviation 4.76 |
| COR-001 6 mg | Chloride: Week 24 | 98.7 mmol/L | Standard Deviation 3.15 |
| COR-001 20 mg | Chloride: Week 24 | 97.6 mmol/L | Standard Deviation 3.73 |
Secondary
Cholesterol: Week 12
The observed values of cholesterol at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Cholesterol: Week 12 | 140.4 mg/dL | Standard Deviation 41.24 |
| COR-001 2 mg | Cholesterol: Week 12 | 140.3 mg/dL | Standard Deviation 40.51 |
| COR-001 6 mg | Cholesterol: Week 12 | 145.9 mg/dL | Standard Deviation 41.38 |
| COR-001 20 mg | Cholesterol: Week 12 | 146.0 mg/dL | Standard Deviation 43.54 |
Secondary
Cholesterol: Week 24
The observed values of cholesterol at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Cholesterol: Week 24 | 130.5 mg/dL | Standard Deviation 40.19 |
| COR-001 2 mg | Cholesterol: Week 24 | 148.3 mg/dL | Standard Deviation 38.74 |
| COR-001 6 mg | Cholesterol: Week 24 | 131.2 mg/dL | Standard Deviation 36.17 |
| COR-001 20 mg | Cholesterol: Week 24 | 158.0 mg/dL | Standard Deviation 44.04 |
Secondary
Creatinine: Week 12
The observed values of creatinine at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Creatinine: Week 12 | 9.458 mg/dL | Standard Deviation 2.739 |
| COR-001 2 mg | Creatinine: Week 12 | 9.616 mg/dL | Standard Deviation 2.642 |
| COR-001 6 mg | Creatinine: Week 12 | 9.227 mg/dL | Standard Deviation 2.526 |
| COR-001 20 mg | Creatinine: Week 12 | 10.115 mg/dL | Standard Deviation 3.391 |
Secondary
Creatinine: Week 24
The observed values of creatinine at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Creatinine: Week 24 | 9.086 mg/dL | Standard Deviation 2.26 |
| COR-001 2 mg | Creatinine: Week 24 | 9.173 mg/dL | Standard Deviation 2.541 |
| COR-001 6 mg | Creatinine: Week 24 | 9.027 mg/dL | Standard Deviation 2.216 |
| COR-001 20 mg | Creatinine: Week 24 | 9.703 mg/dL | Standard Deviation 3.714 |
Secondary
Direct Bilirubin: Week 12
The observed values of direct bilirubin at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Direct Bilirubin: Week 12 | 0.101 mg/dL | Standard Deviation 0.071 |
| COR-001 2 mg | Direct Bilirubin: Week 12 | 0.098 mg/dL | Standard Deviation 0.066 |
| COR-001 6 mg | Direct Bilirubin: Week 12 | 0.123 mg/dL | Standard Deviation 0.049 |
| COR-001 20 mg | Direct Bilirubin: Week 12 | 0.118 mg/dL | Standard Deviation 0.059 |
Secondary
Direct Bilirubin: Week 24
The observed values of direct bilirubin at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Direct Bilirubin: Week 24 | 0.105 mg/dL | Standard Deviation 0.081 |
| COR-001 2 mg | Direct Bilirubin: Week 24 | 0.081 mg/dL | Standard Deviation 0.046 |
| COR-001 6 mg | Direct Bilirubin: Week 24 | 0.124 mg/dL | Standard Deviation 0.053 |
| COR-001 20 mg | Direct Bilirubin: Week 24 | 0.102 mg/dL | Standard Deviation 0.042 |
Secondary
Electrocardiogram (ECG)
A summary of the overall ECG interpretation and clinical significance from baseline until the end of the safety follow up period (week 24) is presented and categorized as Normal, Abnormal clinically significant (CS), Abnormal non clinically significant (NCS) and Missing.
Time frame: At baseline, week 6, week 12, week 18 and week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Electrocardiogram (ECG) | Week 18 | Missing | 0 Participants |
| Placebo | Electrocardiogram (ECG) | Week 12 | Missing | 0 Participants |
| Placebo | Electrocardiogram (ECG) | Baseline | Missing | 0 Participants |
| Placebo | Electrocardiogram (ECG) | Week 18 | Abnormal, non clinically significant (NCS) | 4 Participants |
| Placebo | Electrocardiogram (ECG) | Week 18 | Normal | 7 Participants |
| Placebo | Electrocardiogram (ECG) | Week 18 | Abnormal, clinically significant (CS) | 1 Participants |
| Placebo | Electrocardiogram (ECG) | Baseline | Abnormal, clinically significant (CS) | 1 Participants |
| Placebo | Electrocardiogram (ECG) | Week 24 | Abnormal, non clinically significant (NCS) | 7 Participants |
| Placebo | Electrocardiogram (ECG) | Week 6 | Normal | 6 Participants |
| Placebo | Electrocardiogram (ECG) | Week 6 | Abnormal, clinically significant (CS) | 1 Participants |
| Placebo | Electrocardiogram (ECG) | Week 24 | Abnormal, clinically significant (CS) | 1 Participants |
| Placebo | Electrocardiogram (ECG) | Week 6 | Abnormal, non clinically significant (NCS) | 5 Participants |
| Placebo | Electrocardiogram (ECG) | Week 24 | Missing | 1 Participants |
| Placebo | Electrocardiogram (ECG) | Week 6 | Missing | 0 Participants |
| Placebo | Electrocardiogram (ECG) | Baseline | Abnormal, non clinically significant (NCS) | 6 Participants |
| Placebo | Electrocardiogram (ECG) | Week 24 | Normal | 3 Participants |
| Placebo | Electrocardiogram (ECG) | Week 12 | Normal | 4 Participants |
| Placebo | Electrocardiogram (ECG) | Week 12 | Abnormal, clinically significant (CS) | 1 Participants |
| Placebo | Electrocardiogram (ECG) | Baseline | Normal | 5 Participants |
| Placebo | Electrocardiogram (ECG) | Week 12 | Abnormal, non clinically significant (NCS) | 7 Participants |
| COR-001 2 mg | Electrocardiogram (ECG) | Week 6 | Missing | 0 Participants |
| COR-001 2 mg | Electrocardiogram (ECG) | Week 12 | Abnormal, non clinically significant (NCS) | 10 Participants |
| COR-001 2 mg | Electrocardiogram (ECG) | Week 24 | Abnormal, non clinically significant (NCS) | 10 Participants |
| COR-001 2 mg | Electrocardiogram (ECG) | Week 18 | Abnormal, non clinically significant (NCS) | 11 Participants |
| COR-001 2 mg | Electrocardiogram (ECG) | Week 6 | Abnormal, clinically significant (CS) | 1 Participants |
| COR-001 2 mg | Electrocardiogram (ECG) | Week 12 | Missing | 0 Participants |
| COR-001 2 mg | Electrocardiogram (ECG) | Week 24 | Missing | 0 Participants |
| COR-001 2 mg | Electrocardiogram (ECG) | Baseline | Abnormal, non clinically significant (NCS) | 8 Participants |
| COR-001 2 mg | Electrocardiogram (ECG) | Week 18 | Missing | 0 Participants |
| COR-001 2 mg | Electrocardiogram (ECG) | Week 18 | Normal | 4 Participants |
| COR-001 2 mg | Electrocardiogram (ECG) | Baseline | Normal | 7 Participants |
| COR-001 2 mg | Electrocardiogram (ECG) | Week 18 | Abnormal, clinically significant (CS) | 1 Participants |
| COR-001 2 mg | Electrocardiogram (ECG) | Week 6 | Abnormal, non clinically significant (NCS) | 12 Participants |
| COR-001 2 mg | Electrocardiogram (ECG) | Baseline | Missing | 0 Participants |
| COR-001 2 mg | Electrocardiogram (ECG) | Week 12 | Abnormal, clinically significant (CS) | 1 Participants |
| COR-001 2 mg | Electrocardiogram (ECG) | Week 24 | Normal | 5 Participants |
| COR-001 2 mg | Electrocardiogram (ECG) | Week 12 | Normal | 5 Participants |
| COR-001 2 mg | Electrocardiogram (ECG) | Week 6 | Normal | 3 Participants |
| COR-001 2 mg | Electrocardiogram (ECG) | Baseline | Abnormal, clinically significant (CS) | 1 Participants |
| COR-001 2 mg | Electrocardiogram (ECG) | Week 24 | Abnormal, clinically significant (CS) | 1 Participants |
| COR-001 6 mg | Electrocardiogram (ECG) | Week 18 | Normal | 4 Participants |
| COR-001 6 mg | Electrocardiogram (ECG) | Baseline | Normal | 4 Participants |
| COR-001 6 mg | Electrocardiogram (ECG) | Baseline | Abnormal, clinically significant (CS) | 1 Participants |
| COR-001 6 mg | Electrocardiogram (ECG) | Baseline | Abnormal, non clinically significant (NCS) | 11 Participants |
| COR-001 6 mg | Electrocardiogram (ECG) | Baseline | Missing | 0 Participants |
| COR-001 6 mg | Electrocardiogram (ECG) | Week 6 | Normal | 4 Participants |
| COR-001 6 mg | Electrocardiogram (ECG) | Week 6 | Abnormal, clinically significant (CS) | 1 Participants |
| COR-001 6 mg | Electrocardiogram (ECG) | Week 6 | Abnormal, non clinically significant (NCS) | 8 Participants |
| COR-001 6 mg | Electrocardiogram (ECG) | Week 6 | Missing | 3 Participants |
| COR-001 6 mg | Electrocardiogram (ECG) | Week 12 | Normal | 3 Participants |
| COR-001 6 mg | Electrocardiogram (ECG) | Week 12 | Abnormal, clinically significant (CS) | 2 Participants |
| COR-001 6 mg | Electrocardiogram (ECG) | Week 12 | Abnormal, non clinically significant (NCS) | 10 Participants |
| COR-001 6 mg | Electrocardiogram (ECG) | Week 12 | Missing | 1 Participants |
| COR-001 6 mg | Electrocardiogram (ECG) | Week 18 | Abnormal, clinically significant (CS) | 0 Participants |
| COR-001 6 mg | Electrocardiogram (ECG) | Week 18 | Abnormal, non clinically significant (NCS) | 8 Participants |
| COR-001 6 mg | Electrocardiogram (ECG) | Week 18 | Missing | 4 Participants |
| COR-001 6 mg | Electrocardiogram (ECG) | Week 24 | Normal | 5 Participants |
| COR-001 6 mg | Electrocardiogram (ECG) | Week 24 | Abnormal, clinically significant (CS) | 0 Participants |
| COR-001 6 mg | Electrocardiogram (ECG) | Week 24 | Abnormal, non clinically significant (NCS) | 8 Participants |
| COR-001 6 mg | Electrocardiogram (ECG) | Week 24 | Missing | 3 Participants |
| COR-001 20 mg | Electrocardiogram (ECG) | Week 12 | Abnormal, clinically significant (CS) | 1 Participants |
| COR-001 20 mg | Electrocardiogram (ECG) | Week 12 | Normal | 3 Participants |
| COR-001 20 mg | Electrocardiogram (ECG) | Week 24 | Abnormal, non clinically significant (NCS) | 10 Participants |
| COR-001 20 mg | Electrocardiogram (ECG) | Week 18 | Missing | 6 Participants |
| COR-001 20 mg | Electrocardiogram (ECG) | Week 6 | Missing | 3 Participants |
| COR-001 20 mg | Electrocardiogram (ECG) | Week 6 | Abnormal, non clinically significant (NCS) | 10 Participants |
| COR-001 20 mg | Electrocardiogram (ECG) | Baseline | Abnormal, clinically significant (CS) | 1 Participants |
| COR-001 20 mg | Electrocardiogram (ECG) | Week 24 | Normal | 0 Participants |
| COR-001 20 mg | Electrocardiogram (ECG) | Week 6 | Abnormal, clinically significant (CS) | 0 Participants |
| COR-001 20 mg | Electrocardiogram (ECG) | Week 6 | Normal | 4 Participants |
| COR-001 20 mg | Electrocardiogram (ECG) | Baseline | Normal | 7 Participants |
| COR-001 20 mg | Electrocardiogram (ECG) | Week 24 | Abnormal, clinically significant (CS) | 1 Participants |
| COR-001 20 mg | Electrocardiogram (ECG) | Baseline | Missing | 0 Participants |
| COR-001 20 mg | Electrocardiogram (ECG) | Week 18 | Normal | 2 Participants |
| COR-001 20 mg | Electrocardiogram (ECG) | Baseline | Abnormal, non clinically significant (NCS) | 9 Participants |
| COR-001 20 mg | Electrocardiogram (ECG) | Week 18 | Abnormal, clinically significant (CS) | 0 Participants |
| COR-001 20 mg | Electrocardiogram (ECG) | Week 12 | Missing | 2 Participants |
| COR-001 20 mg | Electrocardiogram (ECG) | Week 12 | Abnormal, non clinically significant (NCS) | 11 Participants |
| COR-001 20 mg | Electrocardiogram (ECG) | Week 24 | Missing | 6 Participants |
| COR-001 20 mg | Electrocardiogram (ECG) | Week 18 | Abnormal, non clinically significant (NCS) | 9 Participants |
Secondary
Elimination Half-life in the Initial Phase (t 1/2,α)
Elimination half-life in the initial phase (t 1/2,α) is presented from week 0 to week 35.
Time frame: Week 1 (day 1, 3, and 5), Week 2 (day 8), Week 3 (day 15), Week 5 (day 29), Week 7 (day 43), Week 8 (day 50), Week 9 (day 57), Week 11 (day 71 and 75), Week 14 (day 92), Week 18 (day 120) and Week 35 (day 239).
Population: The PK population included all participants who had any valid samples measured for study drug levels. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Elimination Half-life in the Initial Phase (t 1/2,α) | 2.55 Days | Standard Deviation 0.94 |
| COR-001 2 mg | Elimination Half-life in the Initial Phase (t 1/2,α) | 1.98 Days | Standard Deviation 0.87 |
| COR-001 6 mg | Elimination Half-life in the Initial Phase (t 1/2,α) | 1.90 Days | Standard Deviation 0.7 |
Secondary
Elimination Half-life in the Terminal Phase (t 1/2, z)
Elimination half-life in the terminal phase(t 1/2, z) is presented from week 0 to week 35.
Time frame: Week 1 (day 1, 3, and 5), Week 2 (day 8), Week 3 (day 15), Week 5 (day 29), Week 7 (day 43), Week 8 (day 50), Week 9 (day 57), Week 11 (day 71 and 75), Week 14 (day 92), Week 18 (day 120) and Week 35 (day 239).
Population: The PK population included all participants who had any valid samples measured for study drug levels. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Elimination Half-life in the Terminal Phase (t 1/2, z) | 51.44 Days | Standard Deviation 21.55 |
| COR-001 2 mg | Elimination Half-life in the Terminal Phase (t 1/2, z) | 38.22 Days | Standard Deviation 14.21 |
| COR-001 6 mg | Elimination Half-life in the Terminal Phase (t 1/2, z) | 40.93 Days | Standard Deviation 13.43 |
Secondary
Eosinophils to Leukocytes Ratio: Week 12
Eosinophils to leukocytes ratio at week 12 is presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Eosinophils to Leukocytes Ratio: Week 12 | 3.39 Ratio of eosinophils to leukocytes | Standard Deviation 1.433 |
| COR-001 2 mg | Eosinophils to Leukocytes Ratio: Week 12 | 5.56 Ratio of eosinophils to leukocytes | Standard Deviation 3.234 |
| COR-001 6 mg | Eosinophils to Leukocytes Ratio: Week 12 | 4.14 Ratio of eosinophils to leukocytes | Standard Deviation 1.669 |
| COR-001 20 mg | Eosinophils to Leukocytes Ratio: Week 12 | 7.32 Ratio of eosinophils to leukocytes | Standard Deviation 10.738 |
Secondary
Eosinophils to Leukocytes Ratio: Week 24
The eosinophils to leukocytes ratio at week 24 is presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Eosinophils to Leukocytes Ratio: Week 24 | 3.49 Ratio of eosinophils to leukocytes | Standard Deviation 1.611 |
| COR-001 2 mg | Eosinophils to Leukocytes Ratio: Week 24 | 4.44 Ratio of eosinophils to leukocytes | Standard Deviation 2.287 |
| COR-001 6 mg | Eosinophils to Leukocytes Ratio: Week 24 | 5.32 Ratio of eosinophils to leukocytes | Standard Deviation 4.748 |
| COR-001 20 mg | Eosinophils to Leukocytes Ratio: Week 24 | 3.98 Ratio of eosinophils to leukocytes | Standard Deviation 3.985 |
Secondary
Eosinophils: Week 12
The observed values of eosinophils at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Eosinophils: Week 12 | 0.16 10^3 cells/uL | Standard Deviation 0.07 |
| COR-001 2 mg | Eosinophils: Week 12 | 0.35 10^3 cells/uL | Standard Deviation 0.247 |
| COR-001 6 mg | Eosinophils: Week 12 | 0.18 10^3 cells/uL | Standard Deviation 0.08 |
| COR-001 20 mg | Eosinophils: Week 12 | 0.65 10^3 cells/uL | Standard Deviation 1.706 |
Secondary
Eosinophils: Week 24
The observed values of eosinophils at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Eosinophils: Week 24 | 0.19 10^3 cells/uL | Standard Deviation 0.083 |
| COR-001 2 mg | Eosinophils: Week 24 | 0.29 10^3 cells/uL | Standard Deviation 0.189 |
| COR-001 6 mg | Eosinophils: Week 24 | 0.30 10^3 cells/uL | Standard Deviation 0.336 |
| COR-001 20 mg | Eosinophils: Week 24 | 0.36 10^3 cells/uL | Standard Deviation 0.683 |
Secondary
Erythrocyte Mean Corpuscular Hemoglobin (HGB) Concentration: Week 12
The observed values of erythrocyte mean corpuscular HGB concentration at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Erythrocyte Mean Corpuscular Hemoglobin (HGB) Concentration: Week 12 | 30.86 Grams per deciliter (g/dL) | Standard Deviation 1.332 |
| COR-001 2 mg | Erythrocyte Mean Corpuscular Hemoglobin (HGB) Concentration: Week 12 | 31.41 Grams per deciliter (g/dL) | Standard Deviation 1.438 |
| COR-001 6 mg | Erythrocyte Mean Corpuscular Hemoglobin (HGB) Concentration: Week 12 | 29.75 Grams per deciliter (g/dL) | Standard Deviation 1.563 |
| COR-001 20 mg | Erythrocyte Mean Corpuscular Hemoglobin (HGB) Concentration: Week 12 | 31.23 Grams per deciliter (g/dL) | Standard Deviation 0.978 |
Secondary
Erythrocyte Mean Corpuscular Hemoglobin: Week 12
The observed values of erythrocyte mean corpuscular hemoglobin at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Erythrocyte Mean Corpuscular Hemoglobin: Week 12 | 30.2 pg | Standard Deviation 1.48 |
| COR-001 2 mg | Erythrocyte Mean Corpuscular Hemoglobin: Week 12 | 31.3 pg | Standard Deviation 2.66 |
| COR-001 6 mg | Erythrocyte Mean Corpuscular Hemoglobin: Week 12 | 30.8 pg | Standard Deviation 2.15 |
| COR-001 20 mg | Erythrocyte Mean Corpuscular Hemoglobin: Week 12 | 31.2 pg | Standard Deviation 2.48 |
Secondary
Erythrocyte Mean Corpuscular Hemoglobin: Week 24
The observed values of erythrocyte mean corpuscular hemoglobin at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Erythrocyte Mean Corpuscular Hemoglobin: Week 24 | 29.5 pg | Standard Deviation 2.54 |
| COR-001 2 mg | Erythrocyte Mean Corpuscular Hemoglobin: Week 24 | 31.0 pg | Standard Deviation 2.8 |
| COR-001 6 mg | Erythrocyte Mean Corpuscular Hemoglobin: Week 24 | 30.6 pg | Standard Deviation 2.4 |
| COR-001 20 mg | Erythrocyte Mean Corpuscular Hemoglobin: Week 24 | 29.6 pg | Standard Deviation 2.46 |
Secondary
Erythrocyte Mean Corpuscular HGB Concentration: Week 24
The observed values of erythrocyte mean corpuscular HGB concentration at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Erythrocyte Mean Corpuscular HGB Concentration: Week 24 | 30.78 g/dL | Standard Deviation 1.572 |
| COR-001 2 mg | Erythrocyte Mean Corpuscular HGB Concentration: Week 24 | 31.04 g/dL | Standard Deviation 1.307 |
| COR-001 6 mg | Erythrocyte Mean Corpuscular HGB Concentration: Week 24 | 29.52 g/dL | Standard Deviation 1.799 |
| COR-001 20 mg | Erythrocyte Mean Corpuscular HGB Concentration: Week 24 | 30.28 g/dL | Standard Deviation 1.297 |
Secondary
Erythrocyte Mean Corpuscular Volume: Week 12
The observed values of erythrocyte mean corpuscular volume at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Erythrocyte Mean Corpuscular Volume: Week 12 | 98.16 femtoliters (fL) | Standard Deviation 4.328 |
| COR-001 2 mg | Erythrocyte Mean Corpuscular Volume: Week 12 | 99.35 femtoliters (fL) | Standard Deviation 6.923 |
| COR-001 6 mg | Erythrocyte Mean Corpuscular Volume: Week 12 | 103.49 femtoliters (fL) | Standard Deviation 9.153 |
| COR-001 20 mg | Erythrocyte Mean Corpuscular Volume: Week 12 | 99.97 femtoliters (fL) | Standard Deviation 8.089 |
Secondary
Erythrocyte Mean Corpuscular Volume: Week 24
The observed values of erythrocyte mean corpuscular volume at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Erythrocyte Mean Corpuscular Volume: Week 24 | 95.70 fL | Standard Deviation 6.096 |
| COR-001 2 mg | Erythrocyte Mean Corpuscular Volume: Week 24 | 99.69 fL | Standard Deviation 6.859 |
| COR-001 6 mg | Erythrocyte Mean Corpuscular Volume: Week 24 | 103.53 fL | Standard Deviation 8.55 |
| COR-001 20 mg | Erythrocyte Mean Corpuscular Volume: Week 24 | 97.76 fL | Standard Deviation 6.983 |
Secondary
Erythrocytes: Week 12
The observed values of erythrocytes at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Erythrocytes: Week 12 | 3.464 10^6 cells per microliter(10^6 cells/uL) | Standard Deviation 0.302 |
| COR-001 2 mg | Erythrocytes: Week 12 | 3.348 10^6 cells per microliter(10^6 cells/uL) | Standard Deviation 0.438 |
| COR-001 6 mg | Erythrocytes: Week 12 | 3.459 10^6 cells per microliter(10^6 cells/uL) | Standard Deviation 0.411 |
| COR-001 20 mg | Erythrocytes: Week 12 | 3.370 10^6 cells per microliter(10^6 cells/uL) | Standard Deviation 0.345 |
Secondary
Erythrocytes: Week 24
The observed values of erythrocytes at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Erythrocytes: Week 24 | 3.312 10^6 cells/uL | Standard Deviation 0.48 |
| COR-001 2 mg | Erythrocytes: Week 24 | 3.256 10^6 cells/uL | Standard Deviation 0.347 |
| COR-001 6 mg | Erythrocytes: Week 24 | 3.111 10^6 cells/uL | Standard Deviation 0.388 |
| COR-001 20 mg | Erythrocytes: Week 24 | 3.365 10^6 cells/uL | Standard Deviation 0.513 |
Secondary
Glucose: Week 12
The observed values of glucose at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Glucose: Week 12 | 123.1 mg/dL | Standard Deviation 52.29 |
| COR-001 2 mg | Glucose: Week 12 | 128.5 mg/dL | Standard Deviation 66.17 |
| COR-001 6 mg | Glucose: Week 12 | 119.6 mg/dL | Standard Deviation 73.49 |
| COR-001 20 mg | Glucose: Week 12 | 101.2 mg/dL | Standard Deviation 19.86 |
Secondary
Glucose: Week 24
The observed values of glucose at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Glucose: Week 24 | 129.5 mg/dL | Standard Deviation 54.83 |
| COR-001 2 mg | Glucose: Week 24 | 129.9 mg/dL | Standard Deviation 64.12 |
| COR-001 6 mg | Glucose: Week 24 | 142.4 mg/dL | Standard Deviation 168.55 |
| COR-001 20 mg | Glucose: Week 24 | 104.2 mg/dL | Standard Deviation 22.97 |
Secondary
HDL Cholesterol: Week 24
The observed values of HDL cholesterol at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | HDL Cholesterol: Week 24 | 50.5 mg/dL | Standard Deviation 17.33 |
| COR-001 2 mg | HDL Cholesterol: Week 24 | 45.4 mg/dL | Standard Deviation 16.02 |
| COR-001 6 mg | HDL Cholesterol: Week 24 | 48.8 mg/dL | Standard Deviation 16.29 |
| COR-001 20 mg | HDL Cholesterol: Week 24 | 46.8 mg/dL | Standard Deviation 22.49 |
Secondary
Hematocrit: Week 12
The observed values of hematocrit at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Hematocrit: Week 12 | 34.0 Percentage of Hematocrit | Standard Deviation 3.43 |
| COR-001 2 mg | Hematocrit: Week 12 | 33.1 Percentage of Hematocrit | Standard Deviation 3.31 |
| COR-001 6 mg | Hematocrit: Week 12 | 35.6 Percentage of Hematocrit | Standard Deviation 3.13 |
| COR-001 20 mg | Hematocrit: Week 12 | 33.7 Percentage of Hematocrit | Standard Deviation 4.24 |
Secondary
Hematocrit: Week 24
The observed values of hematocrit at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Hematocrit: Week 24 | 31.5 Percentage of Hematocrit | Standard Deviation 3.72 |
| COR-001 2 mg | Hematocrit: Week 24 | 32.4 Percentage of Hematocrit | Standard Deviation 2.78 |
| COR-001 6 mg | Hematocrit: Week 24 | 32.2 Percentage of Hematocrit | Standard Deviation 4.11 |
| COR-001 20 mg | Hematocrit: Week 24 | 32.8 Percentage of Hematocrit | Standard Deviation 3.58 |
Secondary
Hemoglobin: Week 12
The observed values of hemoglobin at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Hemoglobin: Week 12 | 10.51 g/dL | Standard Deviation 1.19 |
| COR-001 2 mg | Hemoglobin: Week 12 | 10.37 g/dL | Standard Deviation 0.928 |
| COR-001 6 mg | Hemoglobin: Week 12 | 10.56 g/dL | Standard Deviation 1.018 |
| COR-001 20 mg | Hemoglobin: Week 12 | 10.53 g/dL | Standard Deviation 1.36 |
Secondary
Hemoglobin: Week 24
The observed values of hemoglobin at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Hemoglobin: Week 24 | 9.68 g/dL | Standard Deviation 1.057 |
| COR-001 2 mg | Hemoglobin: Week 24 | 10.06 g/dL | Standard Deviation 1.031 |
| COR-001 6 mg | Hemoglobin: Week 24 | 9.47 g/dL | Standard Deviation 1.135 |
| COR-001 20 mg | Hemoglobin: Week 24 | 9.87 g/dL | Standard Deviation 1.215 |
Secondary
Hepcidin-25: Week 12
The observed values of hepcidin-25 at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Hepcidin-25: Week 12 | 310.67 nanogram/milliliter (ng/mL) | Standard Deviation 163.569 |
| COR-001 2 mg | Hepcidin-25: Week 12 | 344.99 nanogram/milliliter (ng/mL) | Standard Deviation 154.189 |
| COR-001 6 mg | Hepcidin-25: Week 12 | 288.72 nanogram/milliliter (ng/mL) | Standard Deviation 210.049 |
| COR-001 20 mg | Hepcidin-25: Week 12 | 233.89 nanogram/milliliter (ng/mL) | Standard Deviation 114.748 |
Secondary
Hepcidin-25: Week 24
The observed values of hepcidin-25 at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Hepcidin-25: Week 24 | 347.55 ng/mL | Standard Deviation 167.752 |
| COR-001 2 mg | Hepcidin-25: Week 24 | 328.35 ng/mL | Standard Deviation 159.543 |
| COR-001 6 mg | Hepcidin-25: Week 24 | 302.72 ng/mL | Standard Deviation 131.966 |
| COR-001 20 mg | Hepcidin-25: Week 24 | 262.18 ng/mL | Standard Deviation 118.461 |
Secondary
High-density Lipoprotein (HDL) Cholesterol: Week 12
The observed values of HDL cholesterol at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | High-density Lipoprotein (HDL) Cholesterol: Week 12 | 51.6 mg/dL | Standard Deviation 16.47 |
| COR-001 2 mg | High-density Lipoprotein (HDL) Cholesterol: Week 12 | 50.1 mg/dL | Standard Deviation 18.05 |
| COR-001 6 mg | High-density Lipoprotein (HDL) Cholesterol: Week 12 | 54.2 mg/dL | Standard Deviation 17.17 |
| COR-001 20 mg | High-density Lipoprotein (HDL) Cholesterol: Week 12 | 52.5 mg/dL | Standard Deviation 15.14 |
Secondary
Hypochromatic Red Cells Week 12
The observed values of hypochromatic red cells at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Hypochromatic Red Cells Week 12 | 13.65 Percentage of Hypochromatic red cells | Standard Deviation 15.015 |
| COR-001 2 mg | Hypochromatic Red Cells Week 12 | 12.09 Percentage of Hypochromatic red cells | Standard Deviation 11.191 |
| COR-001 6 mg | Hypochromatic Red Cells Week 12 | 23.65 Percentage of Hypochromatic red cells | Standard Deviation 22.214 |
| COR-001 20 mg | Hypochromatic Red Cells Week 12 | 11.99 Percentage of Hypochromatic red cells | Standard Deviation 14.657 |
Secondary
Hypochromatic Red Cells: Week 24
The observed values of hypochromatic red cells at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Hypochromatic Red Cells: Week 24 | 11.88 Percentage of Hypochromatic red cells | Standard Deviation 10.819 |
| COR-001 2 mg | Hypochromatic Red Cells: Week 24 | 11.60 Percentage of Hypochromatic red cells | Standard Deviation 11.895 |
| COR-001 6 mg | Hypochromatic Red Cells: Week 24 | 32.02 Percentage of Hypochromatic red cells | Standard Deviation 25.224 |
| COR-001 20 mg | Hypochromatic Red Cells: Week 24 | 15.44 Percentage of Hypochromatic red cells | Standard Deviation 13.415 |
Secondary
Impact of ADAs on Pharmacokinetics
Presence of ADA was a covariate for pharmacokinetics (PK) affecting V1 (volume of distribution for the central compartment). Impact of ADAs on V1 from baseline to week 35 is presented. In the below table, result presented is the bootstrap parameter estimate of the effect of ADA on V1 for a PK model that includes data for all arms combined.
Time frame: Week 1 (day 1, 3, and 5), Week 2 (day 8), Week 3 (day 15), Week 5 (day 29), Week 7 (day 43), Week 8 (day 50), Week 9 (day 57), Week 11 (day 71 and 75), Week 14 (day 92), Week 18 (day 120) and Week 35 (day 239).
Population: The PK population included all participants who had any valid samples measured for study drug levels. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | Impact of ADAs on Pharmacokinetics | 0.361 Milliliter (mL) |
Secondary
LDL Cholesterol: Week 24
The observed values of LDL cholesterol at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | LDL Cholesterol: Week 24 | 60.9 mg/dL | Standard Deviation 32.59 |
| COR-001 2 mg | LDL Cholesterol: Week 24 | 69.4 mg/dL | Standard Deviation 30.44 |
| COR-001 6 mg | LDL Cholesterol: Week 24 | 54.7 mg/dL | Standard Deviation 27.73 |
| COR-001 20 mg | LDL Cholesterol: Week 24 | 82.7 mg/dL | Standard Deviation 35.43 |
Secondary
Leukocytes: Week 12
The observed values of leukocytes at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Leukocytes: Week 12 | 5.23 10^3 cells/uL | Standard Deviation 1.718 |
| COR-001 2 mg | Leukocytes: Week 12 | 5.84 10^3 cells/uL | Standard Deviation 1.837 |
| COR-001 6 mg | Leukocytes: Week 12 | 4.68 10^3 cells/uL | Standard Deviation 1.069 |
| COR-001 20 mg | Leukocytes: Week 12 | 5.25 10^3 cells/uL | Standard Deviation 3.004 |
Secondary
Leukocytes: Week 24
The observed values of leukocytes at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Leukocytes: Week 24 | 5.52 10^3 cells/uL | Standard Deviation 2.197 |
| COR-001 2 mg | Leukocytes: Week 24 | 6.06 10^3 cells/uL | Standard Deviation 1.689 |
| COR-001 6 mg | Leukocytes: Week 24 | 5.52 10^3 cells/uL | Standard Deviation 1.168 |
| COR-001 20 mg | Leukocytes: Week 24 | 6.13 10^3 cells/uL | Standard Deviation 3.414 |
Secondary
Lipoprotein-a: Week 12
The observed values of lipoprotein-a at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Lipoprotein-a: Week 12 | 35.2 Nanomoles per litre (nmol/L) | Standard Deviation 38.88 |
| COR-001 2 mg | Lipoprotein-a: Week 12 | 86.3 Nanomoles per litre (nmol/L) | Standard Deviation 83.29 |
| COR-001 6 mg | Lipoprotein-a: Week 12 | 68.9 Nanomoles per litre (nmol/L) | Standard Deviation 50.11 |
| COR-001 20 mg | Lipoprotein-a: Week 12 | 53.1 Nanomoles per litre (nmol/L) | Standard Deviation 41.54 |
Secondary
Lipoprotein-a: Week 24
The observed values of lipoprotein-a at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Lipoprotein-a: Week 24 | 39.3 nmol/L | Standard Deviation 37.6 |
| COR-001 2 mg | Lipoprotein-a: Week 24 | 96.6 nmol/L | Standard Deviation 92.52 |
| COR-001 6 mg | Lipoprotein-a: Week 24 | 89.5 nmol/L | Standard Deviation 61.25 |
| COR-001 20 mg | Lipoprotein-a: Week 24 | 61.9 nmol/L | Standard Deviation 52.28 |
Secondary
Low-density Lipoproteins (LDL) Cholesterol: Week 12
The observed values of LDL cholesterol at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Low-density Lipoproteins (LDL) Cholesterol: Week 12 | 67.2 mg/dL | Standard Deviation 29.62 |
| COR-001 2 mg | Low-density Lipoproteins (LDL) Cholesterol: Week 12 | 61.4 mg/dL | Standard Deviation 31.4 |
| COR-001 6 mg | Low-density Lipoproteins (LDL) Cholesterol: Week 12 | 63.8 mg/dL | Standard Deviation 32.69 |
| COR-001 20 mg | Low-density Lipoproteins (LDL) Cholesterol: Week 12 | 68.1 mg/dL | Standard Deviation 39.58 |
Secondary
Lymphocytes to Leukocytes Ratio at Week 24
Lymphocytes to leukocytes ratio at week 24 is presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Lymphocytes to Leukocytes Ratio at Week 24 | 21.47 Ratio of lymphocytes to leukocytes | Standard Deviation 11.35 |
| COR-001 2 mg | Lymphocytes to Leukocytes Ratio at Week 24 | 21.24 Ratio of lymphocytes to leukocytes | Standard Deviation 7.195 |
| COR-001 6 mg | Lymphocytes to Leukocytes Ratio at Week 24 | 20.63 Ratio of lymphocytes to leukocytes | Standard Deviation 6.997 |
| COR-001 20 mg | Lymphocytes to Leukocytes Ratio at Week 24 | 21.71 Ratio of lymphocytes to leukocytes | Standard Deviation 7.633 |
Secondary
Lymphocytes to Leukocytes Ratio: Week 12
Lymphocytes to leukocytes ratio at week 12 is presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Lymphocytes to Leukocytes Ratio: Week 12 | 22.86 Ratio of lymphocytes to leukocytes | Standard Deviation 9.139 |
| COR-001 2 mg | Lymphocytes to Leukocytes Ratio: Week 12 | 25.09 Ratio of lymphocytes to leukocytes | Standard Deviation 9.611 |
| COR-001 6 mg | Lymphocytes to Leukocytes Ratio: Week 12 | 24.15 Ratio of lymphocytes to leukocytes | Standard Deviation 5.774 |
| COR-001 20 mg | Lymphocytes to Leukocytes Ratio: Week 12 | 24.81 Ratio of lymphocytes to leukocytes | Standard Deviation 7.341 |
Secondary
Lymphocytes: Week 12
The observed values of lymphocytes at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Lymphocytes: Week 12 | 1.10 10^3 cells/uL | Standard Deviation 0.306 |
| COR-001 2 mg | Lymphocytes: Week 12 | 1.45 10^3 cells/uL | Standard Deviation 0.678 |
| COR-001 6 mg | Lymphocytes: Week 12 | 1.11 10^3 cells/uL | Standard Deviation 0.25 |
| COR-001 20 mg | Lymphocytes: Week 12 | 1.18 10^3 cells/uL | Standard Deviation 0.388 |
Secondary
Lymphocytes: Week 24
The observed values of lymphocytes at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Lymphocytes: Week 24 | 1.10 10^3 cells/uL | Standard Deviation 0.452 |
| COR-001 2 mg | Lymphocytes: Week 24 | 1.26 10^3 cells/uL | Standard Deviation 0.496 |
| COR-001 6 mg | Lymphocytes: Week 24 | 1.08 10^3 cells/uL | Standard Deviation 0.267 |
| COR-001 20 mg | Lymphocytes: Week 24 | 1.23 10^3 cells/uL | Standard Deviation 0.523 |
Secondary
Maximum Serum Concentration (Cmax)
Maximum serum concentration (Cmax) of COR-001 from week 0 to week 35 is presented.
Time frame: Week 1 (day 1, 3, and 5), Week 2 (day 8), Week 3 (day 15), Week 5 (day 29), Week 7 (day 43), Week 8 (day 50), Week 9 (day 57), Week 11 (day 71 and 75), Week 14 (day 92), Week 18 (day 120) and Week 35 (day 239).
Population: The PK population included all participants who had any valid samples measured for study drug levels. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Serum Concentration (Cmax) | 378 ng/mL | Standard Deviation 93 |
| COR-001 2 mg | Maximum Serum Concentration (Cmax) | 1368 ng/mL | Standard Deviation 359 |
| COR-001 6 mg | Maximum Serum Concentration (Cmax) | 3584 ng/mL | Standard Deviation 1349 |
Secondary
Monocytes to Leukocytes Ratio: Week 12
Monocytes to leukocytes ratio at week 12 is presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Monocytes to Leukocytes Ratio: Week 12 | 5.61 Ratio of monocytes to leukocytes | Standard Deviation 2.871 |
| COR-001 2 mg | Monocytes to Leukocytes Ratio: Week 12 | 5.42 Ratio of monocytes to leukocytes | Standard Deviation 2.649 |
| COR-001 6 mg | Monocytes to Leukocytes Ratio: Week 12 | 5.15 Ratio of monocytes to leukocytes | Standard Deviation 1.652 |
| COR-001 20 mg | Monocytes to Leukocytes Ratio: Week 12 | 6.21 Ratio of monocytes to leukocytes | Standard Deviation 2.23 |
Secondary
Monocytes to Leukocytes Ratio: Week 24
Monocytes to leukocytes ratio at week 24 is presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Monocytes to Leukocytes Ratio: Week 24 | 7.04 Ratio of monocytes to leukocytes | Standard Deviation 2.369 |
| COR-001 2 mg | Monocytes to Leukocytes Ratio: Week 24 | 6.29 Ratio of monocytes to leukocytes | Standard Deviation 2.281 |
| COR-001 6 mg | Monocytes to Leukocytes Ratio: Week 24 | 5.49 Ratio of monocytes to leukocytes | Standard Deviation 1.77 |
| COR-001 20 mg | Monocytes to Leukocytes Ratio: Week 24 | 5.77 Ratio of monocytes to leukocytes | Standard Deviation 2.396 |
Secondary
Monocytes: Week 12
The observed values of monocytes at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Monocytes: Week 12 | 0.26 10^3 cells/uL | Standard Deviation 0.151 |
| COR-001 2 mg | Monocytes: Week 12 | 0.29 10^3 cells/uL | Standard Deviation 0.171 |
| COR-001 6 mg | Monocytes: Week 12 | 0.25 10^3 cells/uL | Standard Deviation 0.102 |
| COR-001 20 mg | Monocytes: Week 12 | 0.31 10^3 cells/uL | Standard Deviation 0.119 |
Secondary
Monocytes: Week 24
The observed values of monocytes at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Monocytes: Week 24 | 0.40 10^3 cells/uL | Standard Deviation 0.184 |
| COR-001 2 mg | Monocytes: Week 24 | 0.39 10^3 cells/uL | Standard Deviation 0.2 |
| COR-001 6 mg | Monocytes: Week 24 | 0.31 10^3 cells/uL | Standard Deviation 0.138 |
| COR-001 20 mg | Monocytes: Week 24 | 0.30 10^3 cells/uL | Standard Deviation 0.067 |
Secondary
Neutrophils to Leukocytes Ratio: Week 12
Neutrophils to leukocytes ratio at week 12 is presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Neutrophils to Leukocytes Ratio: Week 12 | 67.29 Ratio of neutrophils to leukocytes | Standard Deviation 11.707 |
| COR-001 2 mg | Neutrophils to Leukocytes Ratio: Week 12 | 62.41 Ratio of neutrophils to leukocytes | Standard Deviation 10.148 |
| COR-001 6 mg | Neutrophils to Leukocytes Ratio: Week 12 | 65.61 Ratio of neutrophils to leukocytes | Standard Deviation 7.447 |
| COR-001 20 mg | Neutrophils to Leukocytes Ratio: Week 12 | 60.79 Ratio of neutrophils to leukocytes | Standard Deviation 9.656 |
Secondary
Neutrophils to Leukocytes Ratio: Week 24
Neutrophils to leukocytes ratio at week 24 is presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Neutrophils to Leukocytes Ratio: Week 24 | 67.37 Ratio of neutrophils to leukocytes | Standard Deviation 13.396 |
| COR-001 2 mg | Neutrophils to Leukocytes Ratio: Week 24 | 67.21 Ratio of neutrophils to leukocytes | Standard Deviation 8.771 |
| COR-001 6 mg | Neutrophils to Leukocytes Ratio: Week 24 | 67.31 Ratio of neutrophils to leukocytes | Standard Deviation 8.293 |
| COR-001 20 mg | Neutrophils to Leukocytes Ratio: Week 24 | 67.94 Ratio of neutrophils to leukocytes | Standard Deviation 8.75 |
Secondary
Neutrophils: Week 12
The observed values of neutrophils at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Neutrophils: Week 12 | 3.68 10^3 cells/uL | Standard Deviation 1.611 |
| COR-001 2 mg | Neutrophils: Week 12 | 3.70 10^3 cells/uL | Standard Deviation 1.455 |
| COR-001 6 mg | Neutrophils: Week 12 | 3.09 10^3 cells/uL | Standard Deviation 0.921 |
| COR-001 20 mg | Neutrophils: Week 12 | 3.09 10^3 cells/uL | Standard Deviation 1.354 |
Secondary
Neutrophils: Week 24
The observed values of neutrophils at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Neutrophils: Week 24 | 3.82 10^3 cells/uL | Standard Deviation 1.795 |
| COR-001 2 mg | Neutrophils: Week 24 | 4.08 10^3 cells/uL | Standard Deviation 1.252 |
| COR-001 6 mg | Neutrophils: Week 24 | 3.71 10^3 cells/uL | Standard Deviation 1.047 |
| COR-001 20 mg | Neutrophils: Week 24 | 4.25 10^3 cells/uL | Standard Deviation 2.507 |
Secondary
Number of Adverse Events of Special Interest
Frequency of events of interest by treatment group and dose from baseline until the end of the safety follow-up period (week 24) were reported. Adverse events of special interest included severe infusion-related reactions, hypersensitivity reaction during study drug infusion, anaphylaxis and neutropenia events of grade 2 or higher (i.e., absolute neutrophil count \<1500/mm\^3 and decline by at least 25% from baseline).
Time frame: Weeks 0-24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Adverse Events of Special Interest | 0 Events |
| COR-001 2 mg | Number of Adverse Events of Special Interest | 0 Events |
| COR-001 6 mg | Number of Adverse Events of Special Interest | 0 Events |
| COR-001 20 mg | Number of Adverse Events of Special Interest | 0 Events |
Secondary
Number of Participants Who Developed Anti-drug Antibodies (ADAs)
Number of participants who developed ADAs from baseline until the end of the extended follow up period (week 35) were reported. Samples with detectable ADAs were classified as positive for ADAs. Samples without detectable ADAs were classified as negative for ADAs.
Time frame: Weeks 0-35
Population: The PK population included all participants who had any valid samples measured for study drug levels.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Who Developed Anti-drug Antibodies (ADAs) | Positive | 2 Participants |
| Placebo | Number of Participants Who Developed Anti-drug Antibodies (ADAs) | Negative | 10 Participants |
| COR-001 2 mg | Number of Participants Who Developed Anti-drug Antibodies (ADAs) | Negative | 14 Participants |
| COR-001 2 mg | Number of Participants Who Developed Anti-drug Antibodies (ADAs) | Positive | 2 Participants |
| COR-001 6 mg | Number of Participants Who Developed Anti-drug Antibodies (ADAs) | Positive | 1 Participants |
| COR-001 6 mg | Number of Participants Who Developed Anti-drug Antibodies (ADAs) | Negative | 15 Participants |
| COR-001 20 mg | Number of Participants Who Developed Anti-drug Antibodies (ADAs) | Positive | 4 Participants |
| COR-001 20 mg | Number of Participants Who Developed Anti-drug Antibodies (ADAs) | Negative | 13 Participants |
Secondary
Number of Participants With ADA Titers
Number of participants with ADA titers for ADA-positive samples from baseline to week 35 is presented.
Time frame: Weeks 0-35
Population: The PK population included all participants who had any valid samples measured for study drug levels.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With ADA Titers | 2 Participants |
| COR-001 2 mg | Number of Participants With ADA Titers | 2 Participants |
| COR-001 6 mg | Number of Participants With ADA Titers | 1 Participants |
| COR-001 20 mg | Number of Participants With ADA Titers | 4 Participants |
Secondary
Number of Participants With Neutralizing ADAs
Number of participants with neutralizing ADAs from baseline to week 35 are presented.
Time frame: From baseline (mean of screening and week 1) to week 35
Population: The PK population included all participants who had any valid samples measured for study drug levels.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Neutralizing ADAs | 0 Participants |
| COR-001 2 mg | Number of Participants With Neutralizing ADAs | 0 Participants |
| COR-001 6 mg | Number of Participants With Neutralizing ADAs | 0 Participants |
| COR-001 20 mg | Number of Participants With Neutralizing ADAs | 0 Participants |
Secondary
Number of Treatment Emergent Adverse Events (TEAEs)
An AE (adverse event) is any undesirable event or any untoward medical occurrence that occurs to a participant during the course of a study, or the protocol-defined time after study termination, whether or not that event is considered Study Drug-related. A TEAE was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of study. Number of TEAEs from baseline until the end of safety follow up (week 24) were presented.
Time frame: Week 0-24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Treatment Emergent Adverse Events (TEAEs) | 33 Events |
| COR-001 2 mg | Number of Treatment Emergent Adverse Events (TEAEs) | 51 Events |
| COR-001 6 mg | Number of Treatment Emergent Adverse Events (TEAEs) | 83 Events |
| COR-001 20 mg | Number of Treatment Emergent Adverse Events (TEAEs) | 66 Events |
Secondary
Phosphate: Week 12
The observed values of phosphate at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Phosphate: Week 12 | 5.06 mg/dL | Standard Deviation 1.425 |
| COR-001 2 mg | Phosphate: Week 12 | 5.67 mg/dL | Standard Deviation 1.905 |
| COR-001 6 mg | Phosphate: Week 12 | 6.51 mg/dL | Standard Deviation 1.364 |
| COR-001 20 mg | Phosphate: Week 12 | 5.43 mg/dL | Standard Deviation 1.416 |
Secondary
Phosphate: Week 24
The observed values of phosphate at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Phosphate: Week 24 | 5.55 mg/dL | Standard Deviation 1.841 |
| COR-001 2 mg | Phosphate: Week 24 | 4.57 mg/dL | Standard Deviation 1.399 |
| COR-001 6 mg | Phosphate: Week 24 | 5.15 mg/dL | Standard Deviation 0.724 |
| COR-001 20 mg | Phosphate: Week 24 | 5.64 mg/dL | Standard Deviation 1.459 |
Secondary
Platelets: Week 12
The observed values of platelets at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Platelets: Week 12 | 169.8 10^3 cells/uL | Standard Deviation 68.37 |
| COR-001 2 mg | Platelets: Week 12 | 168.3 10^3 cells/uL | Standard Deviation 38.62 |
| COR-001 6 mg | Platelets: Week 12 | 129.4 10^3 cells/uL | Standard Deviation 42.26 |
| COR-001 20 mg | Platelets: Week 12 | 143.8 10^3 cells/uL | Standard Deviation 48.68 |
Secondary
Platelets: Week 24
The observed values of platelets at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Platelets: Week 24 | 180.2 10^3 cells/uL | Standard Deviation 62.44 |
| COR-001 2 mg | Platelets: Week 24 | 203.1 10^3 cells/uL | Standard Deviation 57.78 |
| COR-001 6 mg | Platelets: Week 24 | 151.6 10^3 cells/uL | Standard Deviation 41.75 |
| COR-001 20 mg | Platelets: Week 24 | 160.1 10^3 cells/uL | Standard Deviation 55.67 |
Secondary
Potassium: Week 12
The observed values of potassium at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Potassium: Week 12 | 5.13 mmol/L | Standard Deviation 1.094 |
| COR-001 2 mg | Potassium: Week 12 | 5.06 mmol/L | Standard Deviation 0.754 |
| COR-001 6 mg | Potassium: Week 12 | 5.03 mmol/L | Standard Deviation 0.662 |
| COR-001 20 mg | Potassium: Week 12 | 4.69 mmol/L | Standard Deviation 0.647 |
Secondary
Potassium: Week 24
The observed values of potassium at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Potassium: Week 24 | 4.96 mmol/L | Standard Deviation 0.628 |
| COR-001 2 mg | Potassium: Week 24 | 4.97 mmol/L | Standard Deviation 0.581 |
| COR-001 6 mg | Potassium: Week 24 | 4.71 mmol/L | Standard Deviation 0.466 |
| COR-001 20 mg | Potassium: Week 24 | 4.75 mmol/L | Standard Deviation 0.762 |
Secondary
Pre-dialysis Body Mass Index (BMI): Week 12
Pre-dialysis BMI values at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-dialysis Body Mass Index (BMI): Week 12 | 28.952 kilogram per meter^2 (kg/m^2) | Standard Deviation 5.774 |
| COR-001 2 mg | Pre-dialysis Body Mass Index (BMI): Week 12 | 29.668 kilogram per meter^2 (kg/m^2) | Standard Deviation 8.674 |
| COR-001 6 mg | Pre-dialysis Body Mass Index (BMI): Week 12 | 32.150 kilogram per meter^2 (kg/m^2) | Standard Deviation 9.365 |
| COR-001 20 mg | Pre-dialysis Body Mass Index (BMI): Week 12 | 32.574 kilogram per meter^2 (kg/m^2) | Standard Deviation 8.24 |
Secondary
Pre-dialysis Diastolic Blood Pressure: Week 12
Pre-dialysis diastolic blood pressure values at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-dialysis Diastolic Blood Pressure: Week 12 | 84.8 Millimetre of mercury (mm Hg) | Standard Deviation 21.14 |
| COR-001 2 mg | Pre-dialysis Diastolic Blood Pressure: Week 12 | 70.4 Millimetre of mercury (mm Hg) | Standard Deviation 11.7 |
| COR-001 6 mg | Pre-dialysis Diastolic Blood Pressure: Week 12 | 84.2 Millimetre of mercury (mm Hg) | Standard Deviation 10.23 |
| COR-001 20 mg | Pre-dialysis Diastolic Blood Pressure: Week 12 | 76.3 Millimetre of mercury (mm Hg) | Standard Deviation 16.29 |
Secondary
Pre-dialysis Diastolic Blood Pressure: Week 24
Pre-dialysis diastolic blood pressure values at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-dialysis Diastolic Blood Pressure: Week 24 | 76.9 mm Hg | Standard Deviation 13.59 |
| COR-001 2 mg | Pre-dialysis Diastolic Blood Pressure: Week 24 | 77.8 mm Hg | Standard Deviation 13.23 |
| COR-001 6 mg | Pre-dialysis Diastolic Blood Pressure: Week 24 | 74.0 mm Hg | Standard Deviation 14.53 |
| COR-001 20 mg | Pre-dialysis Diastolic Blood Pressure: Week 24 | 78.8 mm Hg | Standard Deviation 13.74 |
Secondary
Pre-dialysis Heart Rate: Week 12
Pre-dialysis heart rate values at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-dialysis Heart Rate: Week 12 | 69.3 beats/min | Standard Deviation 7.5 |
| COR-001 2 mg | Pre-dialysis Heart Rate: Week 12 | 71.1 beats/min | Standard Deviation 12.2 |
| COR-001 6 mg | Pre-dialysis Heart Rate: Week 12 | 70.8 beats/min | Standard Deviation 8.03 |
| COR-001 20 mg | Pre-dialysis Heart Rate: Week 12 | 76.9 beats/min | Standard Deviation 13.37 |
Secondary
Pre-dialysis Heart Rate: Week 24
Pre-dialysis heart rate values at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-dialysis Heart Rate: Week 24 | 71.8 beats/min | Standard Deviation 12.02 |
| COR-001 2 mg | Pre-dialysis Heart Rate: Week 24 | 78.0 beats/min | Standard Deviation 11.9 |
| COR-001 6 mg | Pre-dialysis Heart Rate: Week 24 | 72.6 beats/min | Standard Deviation 10.03 |
| COR-001 20 mg | Pre-dialysis Heart Rate: Week 24 | 78.9 beats/min | Standard Deviation 17.72 |
Secondary
Pre-dialysis Respiration Rate: Week 12
Pre-dialysis respiration rate values at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-dialysis Respiration Rate: Week 12 | 17.8 breaths per minute (breaths/min) | Standard Deviation 1.27 |
| COR-001 2 mg | Pre-dialysis Respiration Rate: Week 12 | 17.9 breaths per minute (breaths/min) | Standard Deviation 1.29 |
| COR-001 6 mg | Pre-dialysis Respiration Rate: Week 12 | 17.9 breaths per minute (breaths/min) | Standard Deviation 1.53 |
| COR-001 20 mg | Pre-dialysis Respiration Rate: Week 12 | 18.1 breaths per minute (breaths/min) | Standard Deviation 1.31 |
Secondary
Pre-dialysis Respiration Rate: Week 24
Pre-dialysis respiration rate values at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-dialysis Respiration Rate: Week 24 | 16.6 breaths/min | Standard Deviation 2.69 |
| COR-001 2 mg | Pre-dialysis Respiration Rate: Week 24 | 18.1 breaths/min | Standard Deviation 1.09 |
| COR-001 6 mg | Pre-dialysis Respiration Rate: Week 24 | 18.3 breaths/min | Standard Deviation 1.6 |
| COR-001 20 mg | Pre-dialysis Respiration Rate: Week 24 | 18.4 breaths/min | Standard Deviation 1.08 |
Secondary
Pre-dialysis Systolic Blood Pressure: Week 12
Pre-dialysis values of systolic blood pressure at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-dialysis Systolic Blood Pressure: Week 12 | 164.4 mm Hg | Standard Deviation 33.13 |
| COR-001 2 mg | Pre-dialysis Systolic Blood Pressure: Week 12 | 143.8 mm Hg | Standard Deviation 21.04 |
| COR-001 6 mg | Pre-dialysis Systolic Blood Pressure: Week 12 | 164.3 mm Hg | Standard Deviation 25.17 |
| COR-001 20 mg | Pre-dialysis Systolic Blood Pressure: Week 12 | 151.4 mm Hg | Standard Deviation 26.83 |
Secondary
Pre-dialysis Systolic Blood Pressure: Week 24
Pre-dialysis values of systolic blood pressure at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-dialysis Systolic Blood Pressure: Week 24 | 149.4 mm Hg | Standard Deviation 30.43 |
| COR-001 2 mg | Pre-dialysis Systolic Blood Pressure: Week 24 | 146.7 mm Hg | Standard Deviation 19.14 |
| COR-001 6 mg | Pre-dialysis Systolic Blood Pressure: Week 24 | 157.6 mm Hg | Standard Deviation 27.45 |
| COR-001 20 mg | Pre-dialysis Systolic Blood Pressure: Week 24 | 155.8 mm Hg | Standard Deviation 22.93 |
Secondary
Pre-dialysis Temperature: Week 12
Pre-dialysis temperature values at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-dialysis Temperature: Week 12 | 36.259 Celsius (C) | Standard Deviation 0.572 |
| COR-001 2 mg | Pre-dialysis Temperature: Week 12 | 36.435 Celsius (C) | Standard Deviation 0.304 |
| COR-001 6 mg | Pre-dialysis Temperature: Week 12 | 36.436 Celsius (C) | Standard Deviation 0.314 |
| COR-001 20 mg | Pre-dialysis Temperature: Week 12 | 36.490 Celsius (C) | Standard Deviation 0.157 |
Secondary
Pre-dialysis Temperature: Week 24
Pre-dialysis temperature values at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-dialysis Temperature: Week 24 | 36.328 C | Standard Deviation 0.384 |
| COR-001 2 mg | Pre-dialysis Temperature: Week 24 | 36.440 C | Standard Deviation 0.315 |
| COR-001 6 mg | Pre-dialysis Temperature: Week 24 | 36.168 C | Standard Deviation 0.37 |
| COR-001 20 mg | Pre-dialysis Temperature: Week 24 | 36.361 C | Standard Deviation 0.251 |
Secondary
Pre-dialysis Weight: Week 12
Pre-dialysis weight values at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-dialysis Weight: Week 12 | 84.583 Kilogram (Kg) | Standard Deviation 18.464 |
| COR-001 2 mg | Pre-dialysis Weight: Week 12 | 82.162 Kilogram (Kg) | Standard Deviation 28.83 |
| COR-001 6 mg | Pre-dialysis Weight: Week 12 | 92.120 Kilogram (Kg) | Standard Deviation 25.72 |
| COR-001 20 mg | Pre-dialysis Weight: Week 12 | 96.213 Kilogram (Kg) | Standard Deviation 29.206 |
Secondary
Pre-infusion BMI: Week 11
Pre-infusion BMI values at week 11 are presented.
Time frame: At week 11
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-infusion BMI: Week 11 | 29.337 Kg/m^2 | Standard Deviation 6.8 |
| COR-001 2 mg | Pre-infusion BMI: Week 11 | 29.399 Kg/m^2 | Standard Deviation 8.267 |
| COR-001 6 mg | Pre-infusion BMI: Week 11 | 31.290 Kg/m^2 | Standard Deviation 8.341 |
| COR-001 20 mg | Pre-infusion BMI: Week 11 | 34.163 Kg/m^2 | Standard Deviation 7.95 |
Secondary
Pre-infusion Diastolic Blood Pressure: Week 11
Pre-infusion diastolic blood pressure values at week 11 are presented.
Time frame: At week 11
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-infusion Diastolic Blood Pressure: Week 11 | 82.3 mm Hg | Standard Deviation 19.68 |
| COR-001 2 mg | Pre-infusion Diastolic Blood Pressure: Week 11 | 66.6 mm Hg | Standard Deviation 10.03 |
| COR-001 6 mg | Pre-infusion Diastolic Blood Pressure: Week 11 | 75.8 mm Hg | Standard Deviation 11.8 |
| COR-001 20 mg | Pre-infusion Diastolic Blood Pressure: Week 11 | 78.7 mm Hg | Standard Deviation 10.71 |
Secondary
Pre-infusion Heart Rate: Week 11
Pre-infusion heart rate values at week 11 are presented.
Time frame: At week 11
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-infusion Heart Rate: Week 11 | 67.1 beats/min | Standard Deviation 6.11 |
| COR-001 2 mg | Pre-infusion Heart Rate: Week 11 | 70.1 beats/min | Standard Deviation 9.44 |
| COR-001 6 mg | Pre-infusion Heart Rate: Week 11 | 65.7 beats/min | Standard Deviation 8.88 |
| COR-001 20 mg | Pre-infusion Heart Rate: Week 11 | 72.8 beats/min | Standard Deviation 9.8 |
Secondary
Pre-infusion Respiration Rate: Week 11
Pre-infusion respiration rate values at week 11 are presented.
Time frame: At week 11
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-infusion Respiration Rate: Week 11 | 18.1 breaths/min | Standard Deviation 1.22 |
| COR-001 2 mg | Pre-infusion Respiration Rate: Week 11 | 17.8 breaths/min | Standard Deviation 1.24 |
| COR-001 6 mg | Pre-infusion Respiration Rate: Week 11 | 18.1 breaths/min | Standard Deviation 1.39 |
| COR-001 20 mg | Pre-infusion Respiration Rate: Week 11 | 18.3 breaths/min | Standard Deviation 1.23 |
Secondary
Pre-infusion Systolic Blood Pressure: Week 11
Pre-infusion systolic blood pressure values at week 11 are presented.
Time frame: At week 11
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-infusion Systolic Blood Pressure: Week 11 | 161.2 mm Hg | Standard Deviation 25.78 |
| COR-001 2 mg | Pre-infusion Systolic Blood Pressure: Week 11 | 138.7 mm Hg | Standard Deviation 27.32 |
| COR-001 6 mg | Pre-infusion Systolic Blood Pressure: Week 11 | 144.0 mm Hg | Standard Deviation 28.3 |
| COR-001 20 mg | Pre-infusion Systolic Blood Pressure: Week 11 | 152.1 mm Hg | Standard Deviation 28.18 |
Secondary
Pre-infusion Temperature: Week 11
Pre-infusion temperature values at week 11 are presented.
Time frame: At week 11
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-infusion Temperature: Week 11 | 36.182 C | Standard Deviation 0.692 |
| COR-001 2 mg | Pre-infusion Temperature: Week 11 | 36.377 C | Standard Deviation 0.259 |
| COR-001 6 mg | Pre-infusion Temperature: Week 11 | 36.187 C | Standard Deviation 0.494 |
| COR-001 20 mg | Pre-infusion Temperature: Week 11 | 36.375 C | Standard Deviation 0.193 |
Secondary
Pre-infusion Weight: Week 11
Pre-infusion weight values at week 11 are presented.
Time frame: At week 11
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-infusion Weight: Week 11 | 86.356 Kg | Standard Deviation 21.881 |
| COR-001 2 mg | Pre-infusion Weight: Week 11 | 83.433 Kg | Standard Deviation 31.58 |
| COR-001 6 mg | Pre-infusion Weight: Week 11 | 92.043 Kg | Standard Deviation 26.401 |
| COR-001 20 mg | Pre-infusion Weight: Week 11 | 91.217 Kg | Standard Deviation 15.121 |
Secondary
Reticulocytes to Erythrocytes Ratio: Week 12
Reticulocytes to erythrocytes ratio at week 12 is presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Reticulocytes to Erythrocytes Ratio: Week 12 | 1.92 Ratio of reticulocytes to erythrocytes | Standard Deviation 0.852 |
| COR-001 2 mg | Reticulocytes to Erythrocytes Ratio: Week 12 | 1.68 Ratio of reticulocytes to erythrocytes | Standard Deviation 0.757 |
| COR-001 6 mg | Reticulocytes to Erythrocytes Ratio: Week 12 | 2.14 Ratio of reticulocytes to erythrocytes | Standard Deviation 1.203 |
| COR-001 20 mg | Reticulocytes to Erythrocytes Ratio: Week 12 | 2.32 Ratio of reticulocytes to erythrocytes | Standard Deviation 1.537 |
Secondary
Reticulocytes to Erythrocytes Ratio: Week 24
Reticulocytes to erythrocytes ratio at week 24 is presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Reticulocytes to Erythrocytes Ratio: Week 24 | 1.95 Ratio of reticulocytes to erythrocytes | Standard Deviation 0.872 |
| COR-001 2 mg | Reticulocytes to Erythrocytes Ratio: Week 24 | 1.96 Ratio of reticulocytes to erythrocytes | Standard Deviation 0.669 |
| COR-001 6 mg | Reticulocytes to Erythrocytes Ratio: Week 24 | 1.84 Ratio of reticulocytes to erythrocytes | Standard Deviation 0.612 |
| COR-001 20 mg | Reticulocytes to Erythrocytes Ratio: Week 24 | 2.24 Ratio of reticulocytes to erythrocytes | Standard Deviation 0.935 |
Secondary
Sodium: Week 12
The observed values of sodium at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Sodium: Week 12 | 135.8 mmol/L | Standard Deviation 2.8 |
| COR-001 2 mg | Sodium: Week 12 | 137.1 mmol/L | Standard Deviation 4.55 |
| COR-001 6 mg | Sodium: Week 12 | 137.4 mmol/L | Standard Deviation 4.03 |
| COR-001 20 mg | Sodium: Week 12 | 138.6 mmol/L | Standard Deviation 3.64 |
Secondary
Sodium: Week 24
The observed values of sodium at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Sodium: Week 24 | 136.7 mmol/L | Standard Deviation 3.04 |
| COR-001 2 mg | Sodium: Week 24 | 136.2 mmol/L | Standard Deviation 4.9 |
| COR-001 6 mg | Sodium: Week 24 | 137.8 mmol/L | Standard Deviation 4.24 |
| COR-001 20 mg | Sodium: Week 24 | 137.2 mmol/L | Standard Deviation 4.06 |
Secondary
Triglycerides: Week 12
The observed values of triglyceride at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Triglycerides: Week 12 | 107.9 mg/dL | Standard Deviation 50.59 |
| COR-001 2 mg | Triglycerides: Week 12 | 140.8 mg/dL | Standard Deviation 131.19 |
| COR-001 6 mg | Triglycerides: Week 12 | 139.5 mg/dL | Standard Deviation 85 |
| COR-001 20 mg | Triglycerides: Week 12 | 126.7 mg/dL | Standard Deviation 89.04 |
Secondary
Triglycerides: Week 24
The observed values of triglycerides at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Triglycerides: Week 24 | 95.4 mg/dL | Standard Deviation 53.98 |
| COR-001 2 mg | Triglycerides: Week 24 | 166.9 mg/dL | Standard Deviation 120.39 |
| COR-001 6 mg | Triglycerides: Week 24 | 146.6 mg/dL | Standard Deviation 147.52 |
| COR-001 20 mg | Triglycerides: Week 24 | 142.9 mg/dL | Standard Deviation 95.94 |
Secondary
Urea Nitrogen: Week 12
The observed values of urea nitrogen at week 12 are presented.
Time frame: At week 12
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Urea Nitrogen: Week 12 | 61.7 mg/dL | Standard Deviation 26.03 |
| COR-001 2 mg | Urea Nitrogen: Week 12 | 61.1 mg/dL | Standard Deviation 17.4 |
| COR-001 6 mg | Urea Nitrogen: Week 12 | 53.3 mg/dL | Standard Deviation 12.38 |
| COR-001 20 mg | Urea Nitrogen: Week 12 | 62.1 mg/dL | Standard Deviation 21.06 |
Secondary
Urea Nitrogen: Week 24
The observed values of urea nitrogen at week 24 are presented.
Time frame: At week 24
Population: The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Urea Nitrogen: Week 24 | 66.2 mg/dL | Standard Deviation 30.04 |
| COR-001 2 mg | Urea Nitrogen: Week 24 | 59.9 mg/dL | Standard Deviation 16.97 |
| COR-001 6 mg | Urea Nitrogen: Week 24 | 51.1 mg/dL | Standard Deviation 13.67 |
| COR-001 20 mg | Urea Nitrogen: Week 24 | 59.6 mg/dL | Standard Deviation 15.11 |