6352138
Last Update Posted: 2024-08-19
Recruiting has not begun
All Genders accepted | 18 Years-65 Years |
280 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Comparative Study of Two Recombinant Human Erythropoietin Products in Chronic Kidney Disease Patients
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
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.
Eligibility
Relevant conditions:
Anemia of Chronic Kidney Disease
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov