Phase 4
Completed N=50
Cost Comparison Study of Darbepoetin Versus Epoetin Therapy to Treat Anemia in Hemodialysis Patients
Source: ClinicalTrials.gov NCT02817555 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Cost of Erythropoiesis Stimulating Agent — 4178.70; 2302.92 dollars Canadian
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cost of Erythropoiesis Stimulating Agent |
4178.70; 2302.92 | — |
| SECONDARY Hemoglobin |
108; 109.8 | — |
| SECONDARY Ferritin |
847.58; 726.29 | — |
| SECONDARY Transferrin Saturation (TSAT) |
26.71; 28.58 | — |
| SECONDARY Iron Dose |
40.36; 41.67 | — |
| SECONDARY Iron Cost |
726.56; 750 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02817555). 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. Informational only — not medical advice.