Comparative Study of Two Recombinant Human Erythropoietin Products in Chronic Kidney Disease Patients

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMegalabs

About this trial

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

Eligibility criteria

Qualifiers

Stage V Chronic kidney disease undergoing hemodialysis

Disqualifiers

Lack of consent to participate in the trial, other severe chronic disease, history of pure red cell aplasia, existence of anti erythropoietin antibodies

Trial design

Treatments tested in this trial

  • Experimental: Epoetin alfa Megalabs® Erythropoietin injectable in intravenous administration.
  • Active comparator: European Union licenced epoetin alfa

Treatment groups

280 Participants
are divided into 2 treatment groups

Sponsors and collaborators