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

Anemia of Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04036253
• Other study ID #: BIOS-HPFS-0115
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 28, 2018
• Est. completion date: January 30, 2022

Study information

• Verified date: January 2021
• Source: Bio Sidus SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: January 30, 2022
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia of Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Biological:
• Erythropoietin alfa
Prefilled syringes of erythropoietin

Locations

Country	Name	City	State
Argentina	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 Fernandez	Caba
Argentina	Hospital Ramos Mejía	Caba
Paraguay	IPHIC	Asunción

Sponsors (1)

Lead Sponsor	Collaborator
Bio Sidus SA

Countries where clinical trial is conducted

Argentina,  Paraguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy Evaluation through the increase of Hemoglobin levels	Evaluate the efficacy of treatment with erythropoietin alfa through increased 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®.	12 weeks of treatment
Primary	Adverse Events and Adverse Reactions (safety and tolerability) at week 12	Evaluate the safety through the incidence of adverse events and adverse reactions after 12 and 24 weeks of treatment, comparing patients treated with HEMAX® PFS versus those treated with EPREX/ ERYPO®.	12 weeks of treatment
Primary	Adverse Events and Adverse Reactions (safety and tolerability) at week 24	Evaluate the safety through the incidence of adverse events and adverse reactions after 12 and 24 weeks of treatment, comparing patients treated with HEMAX® PFS versus those treated with EPREX/ ERYPO®.	24 weeks of treatment
Secondary	Percentage of responders 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®.	12 weeks of treatment
Secondary	Percentage of patients that required any Transfusion	Evaluate the percentage of transfusional requirement after 12 weeks of treatment, comparing patients treated with HEMAX PFS versus those treated with EPREX/ ERYPO®.	12 weeks of treatment
Secondary	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.	Intragroup efficacy until week 12
Secondary	Evaluate the efficacy between arms 24 weeks: week doses in the titration	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	Intragroup efficacy until week 24
Secondary	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	12 and 24 weeks of treatment
Secondary	Concentration of Hepcidin	Hepcidin will be analyzed by ELISA at baseline, week 12 and 24 in order to evaluate the treatment response.	24 weeks of treatment