NCT06352138View on ClinicalTrials.gov

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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

280

Participants

Timeline

Start Date

July 31, 2025

Primary Completion Date

March 31, 2027

Study Completion Date

March 31, 2027

Conditions
Anemia of Chronic Kidney Disease
Interventions
BIOLOGICAL

Experimental: Epoetin alfa Megalabs® Erythropoietin injectable in intravenous administration.

comparison vs the reference product to demonstrate biological similarity

BIOLOGICAL

Active comparator: European Union licenced epoetin alfa

comparison vs. the test product to demonstrate biological similarity

Trial Locations (1)

15000

Megalabs, Colonia Nicolich

All Listed Sponsors
lead

Megalabs

INDUSTRY