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 (ENCASE)

NCT06352138 Phase 3 NOT_YET_RECRUITING

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

Details

Lead sponsor	Megalabs
Phase	Phase 3
Status	NOT_YET_RECRUITING
Enrolment	280
Start date	2025-07
Completion	2027-03

Conditions

• Anemia of Chronic Kidney Disease

Interventions

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

Primary outcomes

• Mean Absolute Change in Hemoglobin Levels — 18 months
  Response to epoetin alfa in patients with chronic kidney failure is an increase in hematocrit, hemoglobin and reduced transfusion requirements. Hemoglobin is the primary endpoint of the study .
• Change in Mean Hb Level — 18 months
  Response to epoetin alfa in patients with chronic kidney failure is an increase in hematocrit, hemoglobin and reduced transfusion requirements. Hemoglobin is the primary endpoint of the study.

Countries

Uruguay