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

Biosidus

Status and phase: Completed; Phase 3

Conditions: Anemia of Chronic Kidney Disease

Treatments: Biological: Erythropoietin alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT04036253

BIOS-HPFS-0115

Details and patient eligibility

About

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®).

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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43 participants in 2 patient groups

Eprex/Erypo

Active Comparator group

Description:

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.

Treatment:

Biological: Erythropoietin alfa

Hemax PFS

Experimental group

Description:

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.

Treatment:

Biological: Erythropoietin alfa