Phase 3
Completed N=140
A Study of Monthly Subcutaneous Continuous Erythropoietin Receptor Activator (CERA) in Predialysis Participants With Chronic Renal Anemia
Source: ClinicalTrials.gov NCT00773968 ↗Enrolled (actual)
140
Serious AEs
9.0%
Results posted
Apr 2016
Primary outcomePrimary: Percentage of Participants Maintaining Their Mean Hb Concentration Within Plus/Minus (±) 1 Grams Per Deciliter (g/dL) of the Reference Range and Between 10.0 and 12.0 g/dL During Efficacy Evaluation Period (EEP) — 65.85 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This single arm study will assess the long term maintenance of hemoglobin (Hb) levels, safety and tolerability of once monthly subcutaneous methoxy polyethylene glycol-epoetin beta (CERA) in predialysis participants with chronic renal anemia. Participants currently receiving subcutaneous darbopoetin alfa maintenance treatment will receive subcutaneous methoxy polyethylene glycol-epoetin beta for a maximum of 32 weeks at a starting dose of 120, 200 or 360 micrograms every 4 weeks according to the dose of darbopoetin alfa administered in Week -1. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10 to 12 grams per deciliter (g/dL).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Maintaining Their Mean Hb Concentration Within Plus/Minus (±) 1 Grams Per Deciliter (g/dL) of the Reference Range and Between 10.0 and 12.0 g/dL During Efficacy Evaluation Period (EEP) |
65.85 | — |
| SECONDARY Change in Hb Concentrations Between EEP and Stability Verification Period (SVP) |
0.27 | — |
| SECONDARY Percentage of Participants Maintaining Hb Concentrations Within the Range of 10.0 to 12.0 g/dL Throughout EEP |
73.17 | — |
| SECONDARY Median Time Spent in the Hb Range of 10.0 to 12.0 g/dL During the EEP |
57.0 | — |
| SECONDARY Percentage of Participants Requiring Any Dose Adjustment During Dose Titration Period (DTP) and EEP |
17.1; 39.0; 22.0; 31.7; 9.8; 9.8 | — |
| SECONDARY Percentage of Participants Who Required Red Blood Cell Transfusions |
0.9 | — |
Eligibility Criteria
Inclusion Criteria
- Chronic renal anemia;
- Continuous subcutaneous maintenance darbopoetin alfa treatment during previous month;
- Hb concentration between 10 and 12 g/dL;
- Adequate iron status.
Exclusion Criteria
- Transfusion of red blood cells during previous 2 months;
- Significant acute or chronic bleeding, such as overt gastrointestinal bleeding;
- Poorly controlled hypertension requiring hospitalization or interruption of darbopoetin alfa treatment in the previous 6 months;
- Active malignant disease.
Data sourced from ClinicalTrials.gov (NCT00773968). 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.