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

Megalabs

Status and phase: Begins enrollment in 2 months; Phase 3

Conditions: Anemia of Chronic Kidney Disease

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

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06352138

ENCASE

Details and patient eligibility

About

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

Full 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.

Enrollment: 280 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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280 participants in 2 patient groups

Epoetin alfa Megalabs® injectable in intravenous application.

Experimental group

Description:

Epoetin alfa Megalabs, Human recombinant epoetin alfa

Treatment:

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

Epoetin alfa Epogen® injectable in intravenous application.

Active Comparator group

Description:

USA licenced Epoetin alfa, Epogen®, Human recombinant epoetin alfa

Treatment:

Biological: Active comparator: European Union licenced epoetin alfa