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NCT06352138 Clinical Trial

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

Anemia of Chronic Kidney Disease Clinical Trial

— ENCASE  

Official title:
Phase III, Multicentre, Double-blind, Randomised, Parallel, Equivalence Clinical Trial to Assess Efficacy, Safety of Megalabs® Recombinant i/v Human Erythropoietin Compared to Eprex® in Anaemia in Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06352138
Other study ID # ENCASE
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date July 2024
Est. completion date March 2027

Study information
Verified date April 2024
Source Megalabs
Contact Medical Director
Phone 59826838000
Email mgiusti@megalabs.global
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 subcutaneous use, compared to Eprex® (Janssen-Cilag Farmacêutica Ltda.), in the treatment of anaemia in participants with chronic renal disease, dependent on haemodialysis

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 280
Est. completion date March 2027
Est. primary completion date March 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• Experimental: Epoetin alfa Megalabs® Erythropoietin injectable in intravenous administration.
comparison vs the reference product to demonstrate biological similarity
• Active comparator: European Union licenced epoetin alfa
comparison vs. the test product to demonstrate biological similarity

Locations
Country Name City State
Uruguay Megalabs Colonia Nicolich Canelones

Sponsors (2)
Lead Sponsor Collaborator
Megalabs Azidus Laboratories

Country where clinical trial is conducted

Uruguay, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 immunogenicity Anti-drug antibodies will be assessed in both groups every two weeks. 18 months
See also
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Completed NCT04543812 - PBF-1681 (Ferric Citrate) for the Treatment of IDA in Patients With NDD-CKD Phase 3
Recruiting NCT05900635 - Effect of Adding Lactoferrin on Oral Iron on Anemia in Chronic Kidney Disease Patients Phase 4
Completed NCT04667533 - Desidustat in the Treatment of Chemotherapy Induced Anemia Phase 1
Completed NCT03731741 - Does Oral Pentoxifylline Administration Improve Hemoglobin in Hemodialysis Patients? Phase 2
Completed NCT02787824 - Periodic Versus Continuous IV Iron Supplementation in HD Patients Phase 4
Completed NCT03431623 - CKD-11101 Phase 3 SC Study Phase 3
Completed NCT01971164 - Safety, Tolerability, PK & PD Study of JTZ-951 in Anemic Subjects With End-stage Renal Disease Phase 1
Recruiting NCT01532349 - Vitamin D as a Modifier of Serum Hepcidin in Children With Chronic Kidney Disease Phase 2
Completed NCT05698420 - Investigation of the Effects of Medium Cut-off Dialyzers Versus High-Flux Dialyzers on Clinical and Laboratory Parameters of Prevalent Hemodialysis Patients
Completed NCT03427801 - Effect of Erythropoiesis-Stimulating Agent Therapy in Patients Receiving Palliative Care of Chronic Kidney Disease
Recruiting NCT03521713 - To Evaluate the Efficacy, Safety, and Immunogenicity of Subcutaneous Eporon Versus Epoetin Alfa (Eprex) Phase 3
Active, not recruiting NCT02754167 - Phase Ib Study to Evaluate PRS-080 in Anemic Chronic Kidney Disease Patients Phase 1/Phase 2
Completed NCT02805244 - Mass Balance Study of JTZ-951 in Subjects With End-stage Renal Disease on Hemodialysis Phase 1
Completed NCT03428594 - CKD-11101 Phase 3 IV Study in Patients Who Had Renal Anemia Receiving Hemodialysis Phase 3
Recruiting NCT06463236 - Clinical Validation of the Management Process for Renal Anemia in Maintenance Hemodialysis Patients N/A

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