MedTrace Logo

Study of HEMAX PFS Versus EPREX/ ERYPO® in Predialysis Chronic Kidney Disease

NCT04036253 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2025-03-20

Study results available
· View outcomes & findings →

Summary

Phase III, multicenter, randomized, open, controlled clinical trial. A study designed as phase III, in 120 patients with chronic renal failure in the pre-dialysis stage, evaluate efficacy and safety of Hemax PFS® (PFS: prefilled syringes) vs the innovator erythropoietin alfa product (Eprex®).

Conditions

  • Anemia of Chronic Kidney Disease

Interventions

BIOLOGICAL

Erythropoietin alfa

Prefilled syringes of erythropoietin

Sponsors & Collaborators

  • Bio Sidus SA

    lead INDUSTRY

Principal Investigators

  • Diego Ambrogetti, MD · Instituto de Investigaciones médicas Alfredo Lanari

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-28
Primary Completion
2021-06-15
Completion
2021-08-31

Countries

  • Argentina
  • Paraguay

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04036253 on ClinicalTrials.gov