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NCT Number: NCT06352138

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

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

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Key information

Conditions

Anemia of Chronic Kidney Disease

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Megalabs

Colonia Nicolich, Departamento de Canelones, 15000, Uruguay

Location contact

Victoria Rodriguez, MD

CONTACT

[email protected]

26836300 ext. 3110

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Biological

comparison vs the reference product to demonstrate biological similarity

Other names: Epoetin alfa Megalabs®, Human recombinant epoetin alfa

Active comparator: European Union licenced epoetin alfa

Biological

comparison vs. the test product to demonstrate biological similarity

Other names: Epogen®, Human recombinant epoetin alfa

Primary outcomes

  1. Mean Absolute Change in Hemoglobin Levels

    Time frame: 18 months

    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 .

  2. Change in Mean Hb Level

    Time frame: 18 months

    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.

Secondary outcomes

  1. immunogenicity

    Time frame: 18 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Marcos Giusti, MD

CONTACT

[email protected]

59826838000

Victoria Rodriguez, MD

CONTACT

[email protected]

59826838000

Sponsors and collaborators

Lead sponsor

Megalabs

Industry

Registry information

Official study title

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

Acronym: ENCASE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 8, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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