Comparative Study of Two Recombinant Human Erythropoietin Products in Chronic Kidney Disease Patients
- Conditions
- Anemia of Chronic Kidney Disease
- Registration Number
- NCT06352138
- Lead Sponsor
- Megalabs
- Brief Summary
Phase III, multicentre, double-blind, randomised, parallel, equivalence clinical trial to determine the efficacy, safety and immunogenicity of Megalabs® recombinant human alfa epoetin for intravenous use, compared to Epogen®, in the treatment of anaemia in participants with chronic renal disease, dependent on haemodialysis
- Detailed Description
Patients with chronic kidney disease undergoing hemodialysis will be administered human recombinant alfa epoetin to revert anemia. Hemoglobin, hematocrit and reticulocyte counts will be assessed. Immunogenicity will be evaluated through bi-weekly Anti Drug Antibody determination. Test drug and comparator drug will be compared to evaluate biosimilarity.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 280
- Stage V Chronic kidney disease undergoing hemodialysis
- Lack of consent to participate in the trial, other severe chronic disease, history of pure red cell aplasia, existence of anti erythropoietin antibodies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in Mean Hb Level 18 months Response to epoetin alfa in patients with chronic kidney failure is an increase in hematocrit, hemoglobin and reduced transfusion requirements.
Hemoglobin is the primary endpoint of the study.Mean Absolute Change in Hemoglobin Levels 18 months Response to epoetin alfa in patients with chronic kidney failure is an increase in hematocrit, hemoglobin and reduced transfusion requirements.
Hemoglobin is the primary endpoint of the study .
- Secondary Outcome Measures
Name Time Method immunogenicity 18 months Anti-drug antibodies will be assessed in both groups every two weeks.
Trial Locations
- Locations (1)
Megalabs
🇺🇾Colonia Nicolich, Canelones, Uruguay