Status:
COMPLETED
Cost Comparison Study of Darbepoetin Versus Epoetin Therapy to Treat Anemia in Hemodialysis Patients
Lead Sponsor:
Andrea L Woodland
Conditions:
Anemia
Chronic Kidney Disease
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine if there is a cost difference between darbepoetin alfa and epoetin alfa when used intravenously to treat anemia in hemodialysis patients.
Detailed Description
Eligible hemodialysis patients who are currently receiving an erythropoiesis stimulating agent (ESA) who enrol and sign consent will be randomized on a 1:1 basis to either remain on epoetin alfa or sw...
Eligibility Criteria
Inclusion
- age ≥19 years
- receiving in-center hemodialysis two or more times weekly
- anemia requiring erythropoiesis stimulating (ESA) agent therapy OR a hemoglobin(Hb)\<100g/L in the absence of other causes of anemia
- if female, must be using an approved method of contraception or judged unable to become pregnant
- able to give informed consent
Exclusion
- acute kidney injury likely to resolve
- plans to change to peritoneal dialysis or home hemodialysis, or planned transplant from a living donor
- expected lifespan of less than six months due to a medical condition other than chronic kidney disease
- current hematologic condition that may cause anemia
- use of medications known to cause anemia
- use of any investigational drug or androgen within 90 days of screening
- significant bleeding within 30 days of screening
- red blood cell transfusion(s) within 30 days of screening
- documented or suspected pure red cell aplasia (PRCA)
- current iron deficiency
- documented allergy or intolerance to intravenous sodium ferric gluconate
- known or probable ESA resistance
- uncontrolled hypertension
- an intention to relocate to a different dialysis center in the near future
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02817555
Start Date
September 1 2010
End Date
May 1 2013
Last Update
September 10 2019
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