Possibia

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