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®).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
43
Prefilled syringes of erythropoietin
CEMEDIC
Buenos Aires, Argentina
CEREHA
Buenos Aires, Argentina
CIMEL
Buenos Aires, Argentina
CIPREC (Centro de Investigación y Prevención Cardiovascular)
CABA, Argentina
Efficacy Evaluation Through Change in Hemoglobin Levels
Evaluate the efficacy of treatment with erythropoietin alfa through the measured changes in levels of hemoglobin from baseline value to the mean value of the 8 to 12 weeks of treatment, comparing patients treated with HEMAX® PFS versus EPREX/ ERYPO®.
Time frame: 12 weeks of treatment
Adverse Events and Adverse Reactions (Safety and Tolerability) at Weeks 12 and 24.
Evaluate the safety through the incidence of adverse events and adverse reactions asessed after 12 and 24 weeks of treatment (week 24 reported which includes those evaluated at week 12), comparing patients treated with HEMAX® PFS versus those treated with EPREX/ ERYPO®.
Time frame: 24 weeks of treatment
Percentage of Responder Patients
Evaluate the efficacy of treatment with erythropoietin alfa through the percentage of responder patients (increase of Hb ≥ 1g/ dl) after 12 weeks of treatment, comparing patients treated with HEMAX® PFS versus those treated with EPREX/ ERYPO®.
Time frame: 12 weeks of treatment
Percentage of Patients That Required Any Transfusion
Evaluate the percentage of transfusional requirements after 12 weeks of treatment, comparing patients treated with HEMAX PFS versus those treated with EPREX/ ERYPO®.
Time frame: 12 weeks of treatment
Change of Hemoglobin Level at Week 12 of Treatment
Evaluate the efficacy between arms (HEMAX® PFS and EPREX/ ERYPO®) of treatment with erythropoietin alfa through the change in the level of hemoglobin from baseline in every visit until the week 12 visit.
Time frame: Intragroup efficacy until week 12
Evaluate the Efficacy Between Arms 24 Weeks: Week Doses in the Titration
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GEMA Consultorio
Caba, Argentina
Hospital Argerich
CABA, Argentina
Hospital Británico de Buenos Aires
CABA, Argentina
Hospital Durand
CABA, Argentina
Hospital Fernandez
CABA, Argentina
Hospital Ramos Mejía
CABA, Argentina
...and 1 more locations
Evaluate the efficacy between arms (HEMAX® PFS and EPREX/ ERYPO®) of the change from the twice - a - week doses in the titration phase to a weekly dose in the maintenance phase through the changes in the hemoglobin levels from week 12 to weeks 16, 20 and 24 of treatment
Time frame: Intragroup efficacy until week 24
Incidence of Anti-drug Antibodies (Immunogenicity)
An anti-erythropoietin alfa antibody determination will be performed to evaluate treatment immunogenicity at week 12 and 24 visit
Time frame: 12 and 24 weeks of treatment
Concentration of Hepcidin
Hepcidin will be analyzed by ELISA at baseline, week 12 and 24 in order to evaluate the treatment response.
Time frame: 24 weeks of treatment