Comparative Study of Two Recombinant Human Erythropoietin Products in Chronic Kidney Disease Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental: Epoetin alfa Megalabs® Erythropoietin injectable in intravenous administration., Active comparator: European Union licenced epoetin alfa.
- Who it may be relevant to
- Registry conditions: Anemia of Chronic Kidney Disease. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Uruguay
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- 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
Primary outcome measures
- Mean Absolute Change in Hemoglobin Levels [Time frame: 18 months]
- Change in Mean Hb Level [Time frame: 18 months]
Secondary outcome measures (1)
- immunogenicity [Time frame: 18 months]
Eligibility criteria
Inclusion criteria
- Stage V Chronic kidney disease undergoing hemodialysis
Exclusion criteria
- Lack of consent to participate in the trial, other severe chronic disease, history of pure red cell aplasia, existence of anti erythropoietin antibodies
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Uruguay · 1 center
- Megalabs — Colonia Nicolich
Identifiers
NCT: NCT06352138 · ENCASE