Phase 3
Completed N=188
STABIL Study: National Study With Mircera for Maintenance of Hemoglobin Level in Dialysis Patients
Source: ClinicalTrials.gov NCT00642850 ↗Enrolled (actual)
188
Serious AEs
21.8%
Results posted
Jun 2016
Primary outcomePrimary: Percentage of Participants Maintaining Average Hemoglobin Concentration Within +/-1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range — 53.3 percentage of participants
◆ Published Evidence
Emerging
10citations · ~1 / year
Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials.
Summary
This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in dialysis participants with chronic renal anemia. Participants will receive monthly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms, according to the dose of epoetin administered in the week preceding first study drug administration. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Linked Publications
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Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Maintaining Average Hemoglobin Concentration Within +/-1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range |
53.3 | — |
| SECONDARY Change in Hemoglobin Concentration Between Reference (SVP) and EEP |
0.0 | — |
| SECONDARY Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP |
57.0 | — |
| SECONDARY Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP |
32 | — |
| SECONDARY Percentage of Participants Requiring Any Dose Adjustment |
75.0; 32.0 | — |
| SECONDARY Number of Participants With Red Blood Cell Transfusion During the Study |
9 | — |
| SECONDARY Number of Participants With Anti-epoetin Antibody |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Chronic renal anemia;
- Continuous stable intravenous maintenance epoetin therapy during previous month;
- Regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.
Exclusion Criteria
- Transfusion of red blood cells during previous 2 months;
- Poorly controlled hypertension, that is, sitting blood pressure exceeding 170/100 millimeter of mercury (mmHg) despite medication;
- Significant acute or chronic bleeding.
Data sourced from ClinicalTrials.gov (NCT00642850) and the linked publication. 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.