Phase 4
Completed N=216
Evaluation of Two Epoetin Alfa Dosing Strategies in Subjects With Chronic Kidney Disease Receiving Hemodialysis
Renal Insufficiency, Chronic · Anemia · Renal Dialysis · Erythrocyte Transfusion
Source: ClinicalTrials.gov NCT02253654 ↗
Enrolled (actual)
216
Serious AEs
36.0%
Results posted
May 2017
Primary outcomePrimary: Percentage of Hemoglobin Measurements Within 10 to 11 g/dL During the Evaluation Period — 46.41; 46.02 percentage of hemoglobin measurements — p=0.46
Summary
The purpose of this study is to compare two different dosing methods of epoetin alfa and their effectiveness in maintaining hemoglobin levels between 10.0 to 11.0 g/dL in in patients with chronic kidney disease (CKD) receiving hemodialysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Hemoglobin Measurements Within 10 to 11 g/dL During the Evaluation Period |
46.41; 46.02 | 0.46 |
| SECONDARY Hemoglobin Concentration at Each Visit |
10.15; 10.04; 10.54; 10.34; 10.66; 10.51 | — |
| SECONDARY Percentage of Participants With Transfusion Events Overall and During Each Study Period |
6.7; 12.0; 2.2; 1.0; 5.6; 10.0 | — |
| SECONDARY Hemoglobin Rate of Change at Each Visit |
0.36; 0.27; 0.10; 0.13; -0.22; -0.19 | — |
| SECONDARY Hemoglobin Intra-subject Variability |
0.74; 0.70 | — |
| SECONDARY Percentage of Participants With Hemoglobin Excursions at Each Visit |
91.0; 93.0; 48.3; 61.0; 80.9; 83.0 | — |
| SECONDARY Weekly Epoetin Alfa Dose at Each Visit |
13139.9; 10400; 9683.7; 6912.5; 8324.2; 6874.0 | — |
| SECONDARY Number of RBC Units Transfused Overall and During Each Study Period |
1; 4; 2; 5; 1; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Informed consent obtained prior to initiation of any study-specific activities/procedures
- Age 18 or older
- Prescribed hemodialysis three times a week (TIW) for ≥ 12 weeks prior to randomization
- Prescribed IV administration of epoetin alfa TIW for ≥ 12 weeks prior to randomization
- Prescribed ≥ 3000 Units/week (ie, ≥ 1000 Units/administration) and 24 hours
- Uncontrolled hypertension, per the investigator within the 4 weeks prior to randomization
- Expected or scheduled solid organ transplant(eg, kidney) within 40 weeks after randomization
- Expected or scheduled to change dialysis modality (eg, peritoneal dialysis, home hemodialysis) within 40 weeks after randomization
Data sourced from ClinicalTrials.gov (NCT02253654). 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.