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

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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06352138

Acronym

ENCASE

Enrollment

280

Registered

2024-04-08

Start date

2025-07-31

Completion date

2027-03-31

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia of Chronic Kidney Disease

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

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.

Interventions

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

comparison vs the reference product to demonstrate biological similarity

BIOLOGICALActive comparator: European Union licenced epoetin alfa

comparison vs. the test product to demonstrate biological similarity

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Intervention model description

multicentre, double-blind, randomised, parallel, equivalence trial

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Mean Absolute Change in Hemoglobin Levels	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 .
Change in Mean Hb Level	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

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

Countries

Uruguay

Contacts

Primary ContactMarcos Giusti, MD

mgiusti@megalabs.global59826838000

Backup ContactVictoria Rodriguez, MD

vrodriguez@megalabs.global59826838000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026