Compares two epoetin alfa products for anemia in chronic kidney disease
Tests a new epoetin alfa against an approved version in adults with kidney-related anemia.
Plain-language title generated from the registry record
Registry title: Comparative Study of Two Recombinant Human Erythropoietin Products in Chronic Kidney Disease Patients
Key facts
- Where
- Colonia Nicolich, UruguaySee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 65 with stage V chronic kidney disease who are on hemodialysis and have anaemia. It compares two epoetin alfa medicines given into a vein.
- Age
- 18 to 65 years
- Sex
- All sexes can join.
- Disease stage
- Stage V chronic kidney disease, treated with hemodialysis.
Main reasons for not taking part
- Does not agree to take part in the trial
- Other severe chronic disease
- History of pure red cell aplasia
- Antibodies against erythropoietin
This trial only enrols participants on dialysis. The registry sentence this rests on: Stage V Chronic kidney disease undergoing hemodialysis
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06352138, who can take part
Where in Uruguay
- MegalabsColonia Nicolich, UruguayNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Megalabs
- Trial code
- NCT06352138
- Record updated
- 19 August 2024
- Original description
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 haemodialysisRead full original descriptionShow less
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
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
Inclusion: Stage V Chronic kidney disease undergoing hemodialysis.
Exclusion: Lack of consent to participate in the trial, other severe chronic disease, history of pure red cell aplasia, existence of anti erythropoietin antibodies.