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

NCT06352138 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2024-08-19

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Megalabs

    lead INDUSTRY

Principal Investigators

  • Satish Kumar, MD · Azidus Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • Uruguay

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06352138 on ClinicalTrials.gov