At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 43 enrolled
Drug / intervention
Erythropoietin alfabiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Erythropoietin alfa for Anemia of Chronic Kidney Disease. Completed, enrolled 43 participants across 11 sites in 2 countries.
Detailed 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®).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia of Chronic Kidney Disease
CountriesArgentina, Paraguay
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartFeb 2018
First PostedJul 2019
Primary CompletionJun 2021
Study CompletionAug 2021
TodayJul 2026
First PostedJul 29, 2019
Enrollment StartFeb 28, 2018
Primary CompletionJun 15, 2021
Study CompletionAug 31, 2021
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 6.9 years ago
Interventions
Erythropoietin alfabiological
Prefilled syringes of erythropoietin