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

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

Sponsors

Lead Sponsor: Bio Sidus SA

Source 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®).

Overall Status Recruiting
Start Date February 28, 2018
Completion Date January 30, 2021
Primary Completion Date September 30, 2020
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Efficacy Evaluation through the increase of Hemoglobin levels 12 weeks of treatment
Adverse Events and Adverse Reactions (safety and tolerability) at week 12 12 weeks of treatment
Adverse Events and Adverse Reactions (safety and tolerability) at week 24 24 weeks of treatment
Secondary Outcome
Measure Time Frame
Percentage of responders 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
Concentration of Hepcidin 24 weeks of treatment
Enrollment 120
Condition
Intervention

Intervention Type: Biological

Intervention Name: Erythropoietin alfa

Description: Prefilled syringes of erythropoietin

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Healthy Volunteers: No

Overall Contact

Last Name: Roberto Diez

Phone: +541149098000

Email: [email protected]

Location
Facility: Status: Contact:
CEMEDIC | Buenos Aires, Argentina Recruiting Carlos Arias
CEREHA | Buenos Aires, Argentina Recruiting Alicia Elbert
CIMEL | Buenos Aires, Argentina Recruiting Liliana Lopez
CIPREC (Centro de Investigación y Prevención Cardiovascular) | Caba, Argentina Recruiting Marcelo de Rosa
GEMA Consultorio | Caba, Argentina Recruiting Leonardo Sivak
Hospital Argerich | Caba, Argentina Recruiting Merdeces Grizzo
Hospital Británico de Buenos Aires | Caba, Argentina Recruiting Hernan Trimarchi
Hospital Durand | Caba, Argentina Recruiting Manuel Canalis
Hospital Fernandez | Caba, Argentina Recruiting Ana Malvar
Hospital Ramos Mejía | Caba, Argentina Recruiting Cristian Kramer
IPHIC | Asunción, Paraguay Recruiting Derlis Gonzalez
Location Countries

Argentina

Paraguay

Verification Date

July 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Eprex/Erypo

Type: Active Comparator

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.

Label: Hemax PFS

Type: Experimental

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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov