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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Anemia of Chronic Kidney Disease
• Intervention / Treatment: Biological: Experimental: Epoetin alfa Megalabs® Erythropoietin injectable in intravenous administration.; Biological: Active comparator: European Union licenced epoetin alfa

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.

• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Victoria Rodriguez, MD; Phone Number: 59826838000; Email: vrodriguez@megalabs.global
• Study Contact Backup: Name: Marcos Giusti, MD; Phone Number: 59826838000; Email: mgiusti@megalabs.global

Study Locations

• Uruguay
  • Canelones
    • Colonia Nicolich, Canelones, Uruguay, 15000
      • Megalabs
      • Contact: Victoria Rodriguez, MD; Phone Number: 3110 26836300; Email: vrodriguez@megalabs.global

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Epoetin alfa Megalabs® injectable in intravenous application.; Epoetin alfa Megalabs, Human recombinant epoetin alfa	Biological: Experimental: Epoetin alfa Megalabs® Erythropoietin injectable in intravenous administration.; comparison vs the reference product to demonstrate biological similarity; Other Names: Epoetin alfa Megalabs®, Human recombinant epoetin alfa
Active Comparator: Epoetin alfa Epogen® injectable in intravenous application.; USA licenced Epoetin alfa, Epogen®, Human recombinant epoetin alfa	Biological: Active comparator: European Union licenced epoetin alfa; comparison vs. the test product to demonstrate biological similarity; Other Names: Epogen®, Human recombinant epoetin alfa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
immunogenicity	Anti-drug antibodies will be assessed in both groups every two weeks.	18 months

Collaborators and Investigators

• Sponsor: Megalabs
• Collaborators: Azidus Laboratories
• Investigators: Study Director: Satish Kumar, MD, Azidus Principal Investigator

Publications and helpful links

Helpful Links

• reference guideline

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: April 1, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 15, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Hematologic Diseases; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: ENCASE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No