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

NCT04036253 | Completed Phase 3 Results DMC

• 1 other identifier: BIOS-HPFS-0115
• Study Type: interventional
• Target: 43
• Locations: 2 countries
• Sites: 11

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®).

Conditions

Anemia of Chronic Kidney Disease

Keywords

epoetin; erythropoietin; Eprex; Hemax; Anemia; Chronic Kidney Disease; pre-dialysis

Outcome Measures

Primary Outcomes (2)

• 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®.

  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®.

  24 weeks of treatment

Secondary Outcomes (6)

• Percentage of Responder Patients

  12 weeks of treatment

• Percentage of Patients That Required Any Transfusion

  12 weeks of treatment

• Change of Hemoglobin Level at Week 12 of Treatment

  Intragroup efficacy until week 12

• Evaluate the Efficacy Between Arms 24 Weeks: Week Doses in the Titration

  Intragroup efficacy until week 24

• Incidence of Anti-drug Antibodies (Immunogenicity)

  12 and 24 weeks of treatment

Study Arms (2)

Eprex/Erypo

ACTIVE COMPARATOR

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.

Biological: Erythropoietin alfa

Hemax PFS

EXPERIMENTAL

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.

Biological: Erythropoietin alfa

Interventions

Erythropoietin alfa BIOLOGICAL

Prefilled syringes of erythropoietin

Eprex/Erypo; Hemax PFS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bio Sidus SA: lead

Study Sites (11)

CEMEDIC

Buenos Aires, Argentina

Location

CEREHA

Buenos Aires, Argentina

Location

CIMEL

Buenos Aires, Argentina

Location

CIPREC (Centro de Investigación y Prevención Cardiovascular)

CABA, Argentina

Location

GEMA Consultorio

Caba, Argentina

Location

Hospital Argerich

CABA, Argentina

Location

Hospital Británico de Buenos Aires

CABA, Argentina

Location

Hospital Durand

CABA, Argentina

Location

Hospital Fernandez

CABA, Argentina

Location

Hospital Ramos Mejía

CABA, Argentina

Location

IPHIC

Asunción, Paraguay

Location

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Biosidus S.A.U.

v.berstein@biosidus.com.ar

+541149098044

Study Officials

• Diego Ambrogetti, MD

  Instituto de Investigaciones médicas Alfredo Lanari

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 29, 2019
• Study Start: February 28, 2018
• Primary Completion: June 15, 2021
• Study Completion: August 31, 2021
• Last Updated: March 20, 2025
• Results First Posted: March 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

AR (10); PA (1)