Trials / Not Yet Recruiting
Not Yet RecruitingNCT06352138
Comparative Study of Two Recombinant Human Erythropoietin Products in Chronic Kidney Disease Patients
Phase III, Multicentre, Double-blind, Randomised, Parallel, Equivalence Clinical Trial to Assess Efficacy, Safety of Megalabs® Recombinant i/v Human Erythropoietin Compared to Epogen® in Anaemia in Patients With Chronic Kidney Disease
- Status
- Not Yet Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 280 (estimated)
- Sponsor
- Megalabs · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Experimental: Epoetin alfa Megalabs® Erythropoietin injectable in intravenous administration. | comparison vs the reference product to demonstrate biological similarity |
| BIOLOGICAL | Active comparator: European Union licenced epoetin alfa | comparison vs. the test product to demonstrate biological similarity |
Timeline
- Start date
- 2025-07-01
- Primary completion
- 2027-03-01
- Completion
- 2027-03-01
- First posted
- 2024-04-08
- Last updated
- 2024-08-19
Locations
1 site across 1 country: Uruguay
Source: ClinicalTrials.gov record NCT06352138. Inclusion in this directory is not an endorsement.