NCT04036253

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

A Randomized, Comparative Study of HEMAX PFS® Versus EPREX/ ERYPO® in the Treatment of Anemia With Epoetin Alfa in Patients With Predialysis Chronic Kidney Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Bio Sidus SA · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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®).

Detailed description

This was a Phase IIIB, multicenter, randomized, open-label study to compare two products with epoetin alfa (HEMAX® PFS versus EPREX/ERYPO®). This trial was open-label for both the patient and the investigator, but blinded in the performance of laboratory analyses. The overall objective of the study was to evaluate the efficacy and the safety of HEMAX® PFS compared to EPREX/ERYPO®, following a dose-titration and maintenance scheme similar to the one used in the regular clinical practice. All patients received HEMAX® PFS or EPREX/ERYPO® twice a week subcutaneously during 12 weeks of titration, switching then to an equivalent weekly dose during 12 additional maintenance weeks. During the dosing scheme switch from twice a week to once weekly, each patient continued receiving the treatment assigned at randomization. The study conclude with n=43 patients.

Conditions

• Anemia of Chronic Kidney Disease

Interventions

Type	Name	Description
BIOLOGICAL	Erythropoietin alfa	Prefilled syringes of erythropoietin

Timeline

• Start date: 2018-02-28
• Primary completion: 2021-06-15
• Completion: 2021-08-31
• First posted: 2019-07-29
• Last updated: 2025-03-20
• Results posted: 2025-03-20

Locations

11 sites across 2 countries: Argentina, Paraguay