Anemia of Chronic Kidney Disease
Conditions
Brief summary
The objective of the study is to evaluate the efficacy and safety of KRX-0502, administered without food, in treating iron deficiency anemia in subjects with stage 3 to 5 non-dialysis dependent chronic kidney disease (NDD-CKD).
Detailed description
Previous clinical trials have tested KRX-0502 administered with food, in dialysis-dependent and NDD-CKD patients. This clinical trial will evaluate the safety and efficacy of KRX-0502 in treating iron deficiency anemia in anemic, stage III to V NDD-CKD patients in a new dosing regimen (without food).
Interventions
DRUGKRX-0502
1g tablets of KRX-0502
Sponsors
Keryx Biopharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and non-lactating females with negative serum pregnancy test (for females of child-bearing potential) at Screening * Age ≥ 18 years * Serum ferritin ≤ 300 ng/mL and TSAT ≤ 25% at Screening * Hemoglobin ≥9.0 g/dL and ≤11.5 g/dL at Screening * eGFR \<60 mL/min at Screening using the 4-variable Modification of Diet in Renal Disease (MDRD) equation
Exclusion criteria
* Subjects receiving phosphate binder medication(s) at, or within 4 weeks prior to, screening * Symptomatic gastrointestinal bleeding, inflammatory bowel disease, inflammatory bowel syndrome and/or Crohn's Disease within 24 weeks prior to \\ Screening * Evidence of acute kidney injury or requirement for dialysis within 8 weeks prior to Screening * Kidney transplant anticipated or start of dialysis expected within 16 weeks of Screening * History of hemochromatosis * IV iron administered within 4 weeks prior to Screening * Erythropoiesis-Stimulating Agent (ESA) administered within 4 weeks prior to Screening * Blood transfusion within 4 weeks prior to Screening * Receipt of any investigational drug within 4 weeks prior to Screening * Cause of anemia other than iron deficiency or chronic kidney disease * History of malignancy in the last five years * Active drug or alcohol dependence or abuse (excluding tobacco use) within the 12 months prior to Screening * Any known allergies to iron products * Previous intolerance to oral ferric citrate * Psychiatric disorder that interferes with the subject's ability to comply with the study protocol * Planned surgery or hospitalization during the trial * Any other medical condition that, in the opinion of the PI, renders the subject unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Hemoglobin From Baseline to the End of 8-week Treatment Period | 8 weeks |
Countries
Israel
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| KRX-0502 KRX-0502 (ferric citrate)
KRX-0502: 1g tablets of KRX-0502 | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | KRX-0502 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 24 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 69.3 years STANDARD_DEVIATION 12.47 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 31 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 32 |
| other Total, other adverse events | 25 / 32 |
| serious Total, serious adverse events | 2 / 32 |
Outcome results
Primary
Change in Hemoglobin From Baseline to the End of 8-week Treatment Period
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KRX-0502 | Change in Hemoglobin From Baseline to the End of 8-week Treatment Period | Baseline | 10.8 g/dL | Standard Deviation 0.77 |
| KRX-0502 | Change in Hemoglobin From Baseline to the End of 8-week Treatment Period | Week 8 | 11.1 g/dL | Standard Deviation 0.81 |