Health Trials

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

ConditionAnemia of Chronic Kidney Disease
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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

    Biological/Vaccine

    comparison vs the reference product to demonstrate biological similarity

  • Active comparator: European Union licenced epoetin alfa

    Biological/Vaccine

    comparison vs. the test product to demonstrate biological similarity

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: Epoetin alfa Megalabs® injectable in intravenous application.Experimental treatment 1 intervention
Group B: Epoetin alfa Epogen® injectable in intravenous application.Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean Absolute Change in Hemoglobin Levels

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 .

Time frame
18 months
2

Change in Mean Hb Level

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.

Time frame
18 months

Secondary outcomes

1

immunogenicity

Anti-drug antibodies will be assessed in both groups every two weeks.

Time frame
18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Megalabs

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: