Loading clinical trials...

Comparative Study of Two Recombinant Human Erythropoietin Products in Chronic Kidney Disease Patients | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE3

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

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

NCT06352138•Megalabs

View on ClinicalTrials.gov

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

Detailed Description

Patients with chronic kidney disease undergoing hemodialysis will be administered human recombinant alfa epoetin to revert anemia. Hemoglobin, hematocrit and reticulocyte counts will be assessed. Immunogenicity will be evaluated through bi-weekly Anti Drug Antibody determination. Test drug and comparator drug will be compared to evaluate biosimilarity.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Stage V Chronic kidney disease undergoing hemodialysis

Exclusion Criteria

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

Locations (1)

Megalabs

Colonia Nicolich, Departamento de Canelones, Uruguay

Key Dates

Start Date

July 1, 2025

Primary Completion Date

March 1, 2027

Completion Date

March 1, 2027

Last Updated

August 19, 2024

Enrollment

280

ESTIMATED participants

Conditions

Anemia of Chronic Kidney Disease

Interventions

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

BIOLOGICAL

Active comparator: European Union licenced epoetin alfa

BIOLOGICAL

Contacts

Marcos Giusti, MD

CONTACT

59826838000 mgiusti@megalabs.global

Victoria Rodriguez, MD

CONTACT

59826838000 vrodriguez@megalabs.global

A Post Marketing Surveillance to Evaluate the Safety of Desidustat for the Treatment of Anemia in Subjects With Chronic Kidney Disease (CKD).(Real World Evidence Study)

NCT05515367

Chronic Kidney DiseasesAnemia of Chronic Kidney Disease

View study

WITHDRAWNPHASE3

Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease Naive to Erythropoiesis-Stimulating Agents

NCT05082584

Anemia of Chronic Kidney Disease

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Post Marketing Surveillance to Evaluate the Safety of Desidustat for the Treatment of Anemia in Subjects With Chronic Kidney Disease (CKD).(Real World Evidence Study)

Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease Naive to Erythropoiesis-Stimulating Agents

Oral Liposomal Iron Versus Injectable Iron Sucrose for Anemia Treatment in Non-Dialysis Chronic Kidney Disease Patients

Effect of Adding Lactoferrin on Oral Iron on Anemia in Chronic Kidney Disease Patients

Desidustat in the Treatment of Chemotherapy Induced Anemia

Project Aura: Co-design of a Home-based Monitoring Service