Clinical trial NCT04036253: Study of HEMAX PFS Versus EPREX/ ERYPO® in Predialysis Chronic Kidney Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia of Chronic Kidney Disease
Keywords: epoetin
erythropoietin
Eprex
Hemax
Anemia
Chronic Kidney Disease
pre-dialysis
Lead sponsor: Bio Sidus SA
Sponsor class: INDUSTRY
First posted: 2019-07-29
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy Evaluation Through Change in Hemoglobin Levels
timeFrame: 12 weeks of treatment
measure: Adverse Events and Adverse Reactions (Safety and Tolerability) at Weeks 12 and 24.
timeFrame: 24 weeks of treatment
Secondary outcomes:
measure: Percentage of Responder Patients
timeFrame: 12 weeks of treatment
measure: Percentage of Patients That Required Any Transfusion
timeFrame: 12 weeks of treatment
measure: Change of Hemoglobin Level at Week 12 of Treatment
timeFrame: Intragroup efficacy until week 12
measure: Evaluate the Efficacy Between Arms 24 Weeks: Week Doses in the Titration
timeFrame: Intragroup efficacy until week 24
measure: Incidence of Anti-drug Antibodies (Immunogenicity)
timeFrame: 12 and 24 weeks of treatment
measure: Concentration of Hepcidin
timeFrame: 24 weeks of treatment
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: CEMEDIC
city: Buenos Aires
country: Argentina
facility: CEREHA
city: Buenos Aires
country: Argentina
facility: CIMEL
city: Caba
country: Argentina
facility: CIPREC (Centro de Investigación y Prevención Cardiovascular)
city: Caba
country: Argentina
facility: GEMA Consultorio
city: Caba
country: Argentina
facility: Hospital Argerich
city: Caba
country: Argentina
facility: Hospital Británico de Buenos Aires
city: Caba
country: Argentina
facility: Hospital Durand
city: Caba
country: Argentina
facility: Hospital Fernandez
city: Caba
country: Argentina
facility: Hospital Ramos Mejía
city: Asunción
country: Paraguay
facility: IPHIC
Study officials:
affiliation: Instituto de Investigaciones médicas Alfredo Lanari
name: Diego Ambrogetti, MD
role: PRINCIPAL_INVESTIGATOR
References: