Anemia of Chronic Kidney DiseasePhase 3NCT04036253
Study of HEMAX PFS Versus EPREX/ ERYPO® in Predialysis Chronic Kidney Disease
A Phase 3 study testing Erythropoietin alfa in people with Anemia of Chronic Kidney Disease, run by Bio Sidus SA at 11 sites in 2 countries.
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®). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Anemia of Chronic Kidney Disease
- What is being tested?
- Erythropoietin alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 28 Feb 2018to 31 Aug 2021
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
Argentina10 sites
CEMEDIC
Buenos Aires
CEREHA
Buenos Aires
CIMEL
Buenos Aires
GEMA Consultorio
Caba
CIPREC (Centro de Investigación y Prevención Cardiovascular)
CABA
Hospital Argerich
CABA
Hospital Británico de Buenos Aires
CABA
Hospital Durand
CABA
Hospital Fernandez
CABA
Hospital Ramos Mejía
CABA
About this study
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
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®).
Read the 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.
- Conditions
- Anemia of Chronic Kidney Disease
- Being tested
- Erythropoietin alfa
- Keywords
- epoetin, erythropoietin, Eprex, Hemax, Anemia, Chronic Kidney Disease, pre-dialysis
- Medical subject headings
- Anemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erythropoietin alfaBiological
Prefilled syringes of erythropoietin
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Erythropoietin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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®.
Measured: 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®.
Measured: 24 weeks of treatment
Secondary outcomes (6)
Percentage of Responder 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®.
Measured: 12 weeks of treatment
Percentage of Patients That Required Any Transfusion
Evaluate the percentage of transfusional requirements after 12 weeks of treatment, comparing patients treated with HEMAX PFS versus those treated with EPREX/ ERYPO®.
Measured: 12 weeks of treatment
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.
Measured: Intragroup efficacy until week 12
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
Measured: Intragroup efficacy until week 24
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
Measured: 12 and 24 weeks of treatment
Concentration of Hepcidin
Hepcidin will be analyzed by ELISA at baseline, week 12 and 24 in order to evaluate the treatment response.
Measured: 24 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start28 Feb 2018
- Primary completion15 Jun 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anemia of Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio Sidus SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Diego Ambrogetti, MD, Principal investigator, Instituto de Investigaciones médicas Alfredo Lanari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036253
- Sponsor's protocol ID
- BIOS-HPFS-0115
- Status last verified
- Feb 2025
- First submitted
- 12 Jul 2019
- Last updated
- 20 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No