Chronic Kidney Disease
Conditions
Keywords
Epoetin alfa, ESA, HX575, CKD
Brief summary
The study will assess the immunogenicity, safety, and efficacy of HX575 epoetin alfa administered subcutaneously (s.c.) in patients suffering from anemia due to chronic kidney disease (CKD)
Interventions
DRUGHX575 epoetin alfa (Sandoz)
Eligible patients are scheduled to receive HX575 (INN: Epoetin alfa) as a solution for injection in order to achieve or maintain the correction of renal anemia.
Sponsors
Sandoz
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
Main Inclusion Criteria: * Adult male and female patients w or w/o dialysis treatment * Stable i.v. or s.c. maintenance therapy with an EU-approved ESA treatment or ESA naïve. * Adequate iron substitution Main
Exclusion criteria
* History of Pure Red Cell Aplasia (PRCA) or anti-erythropoietin (EPO) antibodies * Contraindications for ESA therapy * Serum albumin \< 3.0 g/dL * Immunocompromized patients (immunosuppressive treatment, chemotherapy) * Hepatitis C infection on an active treatment or hepatitis B or human immunodeficiency virus (HIV) infection * Systemic lupus erythematosus * Symptomatic congestive heart failure, Unstable angina pectoris, or myocardial infarction within 6 months * History of malignancy of any organ system within the last 5 years * History of use of any non-EU approved ESA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-Erythropoietin (EPO) Antibodies | 52 weeks | The incidence of antibody formation against epoetin in Radio-immuno-precipitation (RIP) assay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin Level and Change From Baseline Period at Visit 16 (End of Study) | 52 weeks | Actual values of hemoglobin levels at end of study visit and change from Baseline Period (Week -4 to Week -1) |
Countries
Germany, Italy, Poland, Romania, Russia, Turkey (Türkiye), Ukraine
Participant flow
Recruitment details
Patients, suffering from anemia associated with chronic Kidney Disease (CKD), were treated s.c. with HX575 at least once per week in order to achieve and maintain Hb concentration within the target range of 10.0 to 12.0 g/dL. 417 patients were enrolled.
Pre-assignment details
Male and female patients (ESA \[Erythropoiesis Stimulating Agent\]-naïve/on ESA-maintenance therapy, i.v./s.c.) aged 18 years/older, suffering from anemia assoc. with CKD, with/without dialysis treatment. Anemia: Mean Hb conc. \<= 11.0 g/dL for ESA naïve, 9.0-12.0 g/dL for patients receiving ESA therapy.
Participants by arm
| Arm | Count |
|---|---|
| HX575, Safety Population The Study was designed as single arm study with HX575 tested as investigational medicinal product. The safety population (SAF) consisted of all patients that received at least one dose of study drug. 417 patients enrolled, 416 treated. Group includes ESA-naïve patients and patients on ESA-maintenance therapy. | 416 |
| Total | 416 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 10 |
| Overall Study | Death | 21 |
| Overall Study | Kidney transplantation | 10 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Other | 12 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Protocol Violation | 12 |
| Overall Study | Withdrawal by Subject | 24 |
Baseline characteristics
| Characteristic | HX575, Safety Population |
|---|---|
| Age, Continuous | 52.3 years STANDARD_DEVIATION 15.78 |
| Body Mass Index (BMI) | 25.26 kg/m^2 STANDARD_DEVIATION 5.073 |
| ESA pre-treatment ESA maintenance | 166 participants |
| ESA pre-treatment ESA naive | 250 participants |
| Height | 166.9 cm STANDARD_DEVIATION 9.44 |
| 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 | 0 Participants |
| Race (NIH/OMB) White | 416 Participants |
| Region of Enrollment Germany | 5 participants |
| Region of Enrollment Italy | 5 participants |
| Region of Enrollment Poland | 47 participants |
| Region of Enrollment Romania | 40 participants |
| Region of Enrollment Russian Federation | 107 participants |
| Region of Enrollment Turkey | 33 participants |
| Region of Enrollment Ukraine | 179 participants |
| Sex: Female, Male Female | 218 Participants |
| Sex: Female, Male Male | 198 Participants |
| Weight | 70.6 kg STANDARD_DEVIATION 15.92 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 25 / 416 |
| other Total, other adverse events | 121 / 416 |
| serious Total, serious adverse events | 103 / 416 |
Outcome results
Primary
Anti-Erythropoietin (EPO) Antibodies
The incidence of antibody formation against epoetin in Radio-immuno-precipitation (RIP) assay
Time frame: 52 weeks
Population: Safety population: The safety population consists of all patients that received at least one dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HX575 | Anti-Erythropoietin (EPO) Antibodies | 1.7 percentage of participants |
Secondary
Hemoglobin Level and Change From Baseline Period at Visit 16 (End of Study)
Actual values of hemoglobin levels at end of study visit and change from Baseline Period (Week -4 to Week -1)
Time frame: 52 weeks
Population: Per-protocol population (all patients that received at least one dose of study drug) with non-missing Hemoglobin value at Visit 16 (end of study).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HX575 | Hemoglobin Level and Change From Baseline Period at Visit 16 (End of Study) | Actual Value | 10.81 g/dL | Standard Deviation 1.336 |
| HX575 | Hemoglobin Level and Change From Baseline Period at Visit 16 (End of Study) | Change from Baseline Period | 1.61 g/dL | Standard Deviation 1.601 |
| HX575 - ESA Maintenance | Hemoglobin Level and Change From Baseline Period at Visit 16 (End of Study) | Actual Value | 10.86 g/dL | Standard Deviation 1.06 |
| HX575 - ESA Maintenance | Hemoglobin Level and Change From Baseline Period at Visit 16 (End of Study) | Change from Baseline Period | 0.22 g/dL | Standard Deviation 1.223 |
| HX575 | Hemoglobin Level and Change From Baseline Period at Visit 16 (End of Study) | Actual Value | 10.83 g/dL | Standard Deviation 1.226 |
| HX575 | Hemoglobin Level and Change From Baseline Period at Visit 16 (End of Study) | Change from Baseline Period | 1.02 g/dL | Standard Deviation 1.606 |