NCT06352138Not yet recruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 19 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 280 (estimated)
- First submitted
- 11 Mar 2024
- Start date
- 1 Jul 2025
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Megalabs
- Diseases
- Chronic kidney disease
- NCT number
- NCT06352138
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 280
- From 1 Jul 2025 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Lack of consent to participate in the trial, other severe chronic disease, history of pure red cell aplasia, existence of anti erythropoietin antibodies
Who the study is looking for
- Stage V Chronic kidney disease undergoing hemodialysis
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Megalabs Coordinator of this site? Confirm its status | Colonia Nicolich | Uruguay | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.