Phase 3
Completed N=20
A Study of Subcutaneous C.E.R.A. for the Maintenance of Hemoglobin Levels in Participants With Chronic Renal Anemia Not on Dialysis.
Source: ClinicalTrials.gov NCT00642304 ↗Enrolled (actual)
20
Serious AEs
30.0%
Results posted
Nov 2016
Primary outcomePrimary: Percentage of Participants Maintaining Hb Concentration Within +/-1 Gram Per Deciliter (g/dL) of Their Reference Hb and Between 10.5 to 12.5 g/dL Throughout the Efficacy Evaluation Period (EEP) — 40 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 This can indicate results are unpublished — a known publication-bias signal.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 efficacy and safety of subcutaneous C.E.R.A. when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa or epoetin beta will receive monthly injections of C.E.R.A., with the starting dose (120, 200 or 300 micrograms [mcg] subcutaneously [SC]) derived from the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding study start.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Maintaining Hb Concentration Within +/-1 Gram Per Deciliter (g/dL) of Their Reference Hb and Between 10.5 to 12.5 g/dL Throughout the Efficacy Evaluation Period (EEP) |
40 | — |
| SECONDARY Mean Change in Hb Concentration Between SVP and the EEP |
0.2 | — |
| SECONDARY Percentage of Participants Maintaining Hb Concentration Within Hb Range 10.5 to 12.5 g/dL During the EEP |
50.0 | — |
| SECONDARY Mean Time Spent in Hb Range of 10.5 to 12.5 g/dL During the EEP |
36.5 | — |
| SECONDARY Percentage of Participants With Blood Transfusion |
10 | — |
| SECONDARY Percentage of Participants With Dose Adjustment |
60 | — |
Eligibility Criteria
Inclusion Criteria
- Chronic renal anemia
- Stable darbepoetin alfa or epoetin beta therapy for past 8 weeks
Exclusion Criteria
- Transfusion of red blood cells during previous 8 weeks
- Poorly controlled hypertension requiring interruption of epoetin treatment in previous 6 months
- Acute or chronic bleeding requiring therapy within previous 8 weeks
Data sourced from ClinicalTrials.gov (NCT00642304). 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.