Phase 3
Completed N=120
MIRACLE Study: A Study of Once-Monthly Intravenous Mircera in Hemodialysis Participants With Chronic Renal Anemia
Source: ClinicalTrials.gov NCT00545571 ↗Enrolled (actual)
120
Serious AEs
47.3%
Results posted
May 2016
Primary outcomePrimary: Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb or Within Target Range During the Efficacy Evaluation Period (EEP) — 75.6 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 long-term maintenance of hemoglobin levels, safety, and tolerability of once-monthly intravenous administration of Mircera in hemodialysis participants with chronic renal anemia. Those currently receiving darbepoetin alfa, epoetin alfa, or epoetin beta maintenance treatment will receive intravenous Mircera at a starting dose of 120, 200, or 360 micrograms (mcg) per month (based on the erythropoiesis stimulating agent [ESA] dose administered on Week -1). Subsequent doses will be adjusted to maintain hemoglobin levels within the country-specific target range (11 to 13 grams per deciliter [g/dL] for Switzerland and 10 to 12 g/dL for Austria).
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 Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb or Within Target Range During the Efficacy Evaluation Period (EEP) |
75.6 | — |
| SECONDARY Mean Change in Time-Adjusted Hb From Baseline to EEP |
-0.4 | — |
| SECONDARY Mean Time Spent in the Target Range for Hb During the Long-Term Safety Period (LTSP) |
130 | — |
| SECONDARY Percentage of Participants Who Maintained Average Hb Within Target Range Throughout the EEP |
48.4 | — |
| SECONDARY Percentage of Hb Values Above or Below the Target Range During the LTSP |
22; 38 | — |
| SECONDARY Mean Time Spent Above or Below the Target Range for Hb During the LTSP |
43; 48 | — |
| SECONDARY Mean Excursions Above or Below Target Range for Hb During the LTSP |
0.5; -0.7 | — |
| SECONDARY Mean Number of Months a Participant Required Dose Adjustment of Mircera/CERA During the DTP and LTSP |
1.1; 0.4; 0.6; 1.5; 0.7; 0.8 | — |
| SECONDARY Mean Dose of Mircera/CERA During the DTP and LTSP |
140; 133.8 | — |
| SECONDARY Percentage of Participants Who Received Blood Transfusions During the DTP and LTSP |
15.4 | — |
Eligibility Criteria
Inclusion Criteria
- Adults greater than or equal to (≥) 18 years of age
- Chronic renal anemia
- Hemoglobin concentration in country-specific target range (Switzerland: 11 to 13 g/dL; Austria: 10 to 12 g/dL)
- Regular long-term hemodialysis therapy with the same mode of dialysis for ≥3 months
- Continuous intravenous or subcutaneous maintenance ESA treatment during previous 2 months
Exclusion Criteria
- Transfusion of red blood cells during previous 2 months
- Significant acute or chronic bleeding, such as overt gastrointestinal bleeding
- Active malignant disease (except non-melanoma skin cancer)
Data sourced from ClinicalTrials.gov (NCT00545571) 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.