Study of HEMAX PFS Versus EPREX/ ERYPO® in Predialysis Chronic Kidney Disease
- Conditions
- Anemia of Chronic Kidney Disease
- Interventions
- Registration Number
- NCT04036253
- Lead Sponsor
- Bio Sidus SA
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
- Patients older than 18 years
- Patients with pre-dialysis chronic renal failure (CRF) defined by a glomerular filtration rate (calculated with the Modification of Diet in Renal Disease Study formula) ≥15 ml/ min and <60 ml/ min, by 1.73 m2
- Anemic patients that should be treated and levels of hemoglobin <10.5 g/dl and ≥ 7.5 g/dl.
- Patients that have the will and capacity to sign a written inform consent.
- Post-menopause women for at least 2 years, or sterile by surgery for at least 6 months. Women of childbearing age must have a negative pregnancy test at baseline and be willing to get an adequate method of contraception.
- Patients that are planned to be on dialysis or have a renal transplant in the following 6 months.
- Transferrin iron Saturation < 20%.
- Etiology of renal failure (as secondary to autoimmune diseases) that, to the judge to the physician, can affect the normal development of the protocol.
- Active bleeding or history of hemorrhage that have led to a significative decrease of hematocrit in the last 30 days.
- Non-controlled hypertension (≥160 mm Hg of systolic pressure and/or ≥100 mm Hg of diastolic pressure with anti-hypertensive treatment).
- Anemia caused by any other cause than renal disease.
- Having a transfusion in the last 3 months before basal visit or during screening.
- Treatment with an erythropoiesis stimulant in the last 3 months before basal visit or screening.
- Increase risk of thromboembolic disease: history of arterial thromboembolia (stroke, transient ischemic attack, Acute coronary syndrome, etc.) in the last 6 months or venous in the last 12 months before screening; surgery in the last month before screening; prolong immobilization or orthopedic surgery programmed in the following 6 months or any other condition that to the judge of the investigator can increase the risk of thromboembolism.
- Hematological disease or myelodysplastic syndrome or history of hematological neoplasm or solid tumor in the last 5 years.
- History of congestive heart failure
- Pregnancy or breast feeding
- Refuse to participate in the protocol or any medical condition, that in the investigator opinion, is significant to prevent the participant from being included in the trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Eprex/Erypo Erythropoietin alfa Receive EPREX/ ERYPO® subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below. There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks. Hemax PFS Erythropoietin alfa receive HEMAX® PFS subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below. There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks.
- Primary Outcome Measures
Name Time Method Efficacy Evaluation Through Change in Hemoglobin Levels 12 weeks of treatment 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®.
Adverse Events and Adverse Reactions (Safety and Tolerability) at Weeks 12 and 24. 24 weeks of treatment 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®.
- Secondary Outcome Measures
Name Time Method Percentage of Responder Patients 12 weeks of treatment 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®.
Percentage of Patients That Required Any Transfusion 12 weeks of treatment Evaluate the percentage of transfusional requirements after 12 weeks of treatment, comparing patients treated with HEMAX PFS versus those treated with EPREX/ ERYPO®.
Change of Hemoglobin Level at Week 12 of Treatment Intragroup efficacy until week 12 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.
Evaluate the Efficacy Between Arms 24 Weeks: Week Doses in the Titration Intragroup efficacy until week 24 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
Incidence of Anti-drug Antibodies (Immunogenicity) 12 and 24 weeks of treatment An anti-erythropoietin alfa antibody determination will be performed to evaluate treatment immunogenicity at week 12 and 24 visit
Concentration of Hepcidin 24 weeks of treatment Hepcidin will be analyzed by ELISA at baseline, week 12 and 24 in order to evaluate the treatment response.
Trial Locations
- Locations (11)
CEMEDIC
🇦🇷Buenos Aires, Argentina
CEREHA
🇦🇷Buenos Aires, Argentina
CIMEL
🇦🇷Buenos Aires, Argentina
CIPREC (Centro de Investigación y Prevención Cardiovascular)
🇦🇷Caba, Argentina
GEMA Consultorio
🇦🇷Caba, Argentina
Hospital Argerich
🇦🇷Caba, Argentina
Hospital Británico de Buenos Aires
🇦🇷Caba, Argentina
Hospital Durand
🇦🇷Caba, Argentina
Hospital Ramos Mejía
🇦🇷Caba, Argentina
Hospital Fernandez
🇦🇷Caba, Argentina
IPHIC
🇵🇾Asunción, Paraguay