Phase 3
N=43
Study of HEMAX PFS Versus EPREX/ ERYPO® in Predialysis Chronic Kidney Disease
Anemia of Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT04036253 ↗Enrolled (actual)
43
Serious AEs
16.3%
Results posted
Mar 2025
Primary outcome: Primary: Efficacy Evaluation Through Change in Hemoglobin Levels — 9.56; 9.44; 11.05; 11.11 Hemoglobin levels (g/dL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Erythropoietin alfa (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bio Sidus SA
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy Evaluation Through Change in Hemoglobin Levels |
9.56; 9.44; 11.05; 11.11; 1.49; 1.66 | — |
| PRIMARY Adverse Events and Adverse Reactions (Safety and Tolerability) at Weeks 12 and 24. |
23; 30; 4; 4 | — |
| SECONDARY Percentage of Responder Patients |
5.56; 4.55; 94.44; 95.45 | — |
| SECONDARY Percentage of Patients That Required Any Transfusion |
5; 0 | — |
| SECONDARY Change of Hemoglobin Level at Week 12 of Treatment |
9.56; 9.44; 11.05; 11.11; 1.49; 1.66 | — |
| SECONDARY Evaluate the Efficacy Between Arms 24 Weeks: Week Doses in the Titration |
11.08; 11.16; 10.9; 10.82; 10.51; 10.71 | — |
| SECONDARY Incidence of Anti-drug Antibodies (Immunogenicity) |
0; 0; 0; 1 | — |
| SECONDARY Concentration of Hepcidin |
84.80; 74.21; 107.80; 56.07; 83.60; 60.93 | — |
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®).
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.
Data sourced from ClinicalTrials.gov (NCT04036253). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.