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

NCT06352138 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: ENCASE
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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 .

  18 months

• 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.

  18 months

Secondary Outcomes (1)

• immunogenicity

  18 months

Study Arms (2)

Epoetin alfa Megalabs® injectable in intravenous application.

EXPERIMENTAL

Epoetin alfa Megalabs, Human recombinant epoetin alfa

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

Epoetin alfa Epogen® injectable in intravenous application.

ACTIVE COMPARATOR

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

Biological: Active comparator: European Union licenced epoetin alfa

Interventions

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

comparison vs the reference product to demonstrate biological similarity

Also known as: Epoetin alfa Megalabs®, Human recombinant epoetin alfa

Epoetin alfa Megalabs® injectable in intravenous application.

Active comparator: European Union licenced epoetin alfa BIOLOGICAL

comparison vs. the test product to demonstrate biological similarity

Also known as: Epogen®, Human recombinant epoetin alfa

Epoetin alfa Epogen® injectable in intravenous application.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage V Chronic kidney disease undergoing hemodialysis

You may not qualify if:

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

Sponsors & Collaborators

• Megalabs: lead

Study Sites (1)

Megalabs

Colonia Nicolich, Departamento de Canelones, 15000, Uruguay

Location

Related Links

• reference guideline

MeSH Terms

Interventions

Administration, Intravenous; Epoetin Alfa

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Satish Kumar, MD

  Azidus Principal Investigator

  STUDY DIRECTOR

Central Study Contacts

Marcos Giusti, MD

CONTACT

59826838000; mgiusti@megalabs.global

Victoria Rodriguez, MD

CONTACT

59826838000; vrodriguez@megalabs.global

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: multicentre, double-blind, randomised, parallel, equivalence trial

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: April 8, 2024
• Study Start: July 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

UR (1)