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Comparative Study of Two Recombinant Human Erythropoietin Products in Chronic Kidney Disease Patients
Sponsor: Megalabs
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
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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
280
Start Date
2025-07
Completion Date
2027-03
Last Updated
2024-08-19
Healthy Volunteers
No
Conditions
Interventions
Experimental: Epoetin alfa Megalabs® Erythropoietin injectable in intravenous administration.
comparison vs the reference product to demonstrate biological similarity
Active comparator: European Union licenced epoetin alfa
comparison vs. the test product to demonstrate biological similarity
Locations (1)
Megalabs
Colonia Nicolich, Departamento de Canelones, Uruguay