Study of HEMAX PFS Versus EPREX/ ERYPO® in Predialysis Chronic Kidney Disease (NCT04036253) | Clinical Trial Compass
CompletedPhase 3
Study of HEMAX PFS Versus EPREX/ ERYPO® in Predialysis Chronic Kidney Disease
Argentina43 participantsStarted 2018-02-28
Plain-language 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®).
Who can participate
Age range18 Years – 85 Years
SexALL
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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 thromboemboli…
What they're measuring
1
Efficacy Evaluation Through Change in Hemoglobin Levels
Timeframe: 12 weeks of treatment
2
Adverse Events and Adverse Reactions (Safety and Tolerability) at Weeks 12 and 24.