Phase 3
Completed N=132
A Study of Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia
Source: ClinicalTrials.gov NCT00661505 ↗Enrolled (actual)
132
Serious AEs
9.9%
Results posted
Jul 2016
Primary outcomePrimary: Percentage of Participants Who Maintained Their Mean Hemoglobin Concentration Within +/- 1.0 Gram/Deciliter of Their Reference Hemoglobin Concentration and Between 10.0 and 12.0 Gram/Deciliter During the Efficacy Evaluation Period — 46.43 Percentage of participants
◆ Published Evidence
Emerging
9citations · ~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 hemodialysis patients with chronic renal anemia. Patients will receive 4-weekly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms. 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 Who Maintained Their Mean Hemoglobin Concentration Within +/- 1.0 Gram/Deciliter of Their Reference Hemoglobin Concentration and Between 10.0 and 12.0 Gram/Deciliter During the Efficacy Evaluation Period |
46.43 | — |
| SECONDARY Mean Change in Hemoglobin Concentration Between the Stability Verification Period and the Efficacy Evaluation Period |
0.29 | — |
| SECONDARY Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period |
51.18 | — |
| SECONDARY Median Time Spent in the Hemoglobin Range 10.0-12.0 Gram/Deciliter During the Efficacy Evaluation Period |
38.0 | — |
| SECONDARY Mean C.E.R.A. Dose Required to Maintain Hemoglobin Level Within the Range 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period |
103.5 | — |
| SECONDARY Percentage of Participants Requiring Any Dose Adjustments in C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period |
75.6; 36.4 | — |
| SECONDARY Mean Monthly Dose of C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period |
121.6; 112.4 | — |
| SECONDARY Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume at Week 16 and Week 24 |
-2.02; -1.26 | — |
| SECONDARY Mean Change From Baseline in Hematocrit at Week 16 and Week 24 |
0.00; 0.01 | — |
| SECONDARY Mean Change From Baseline in Hemoglobin at Week 16 and Week 24 |
-0.00; 0.22 | — |
| SECONDARY Mean Change From Baseline in Leucocytes and Platelet at Week 16 and Week 24 |
0.27; -0.03; 2.56; 0.17 | — |
| SECONDARY Mean Change From Baseline in Ferritin at Week 16 and Week 24 |
20.80; 31.51 | — |
| SECONDARY Mean Change From Baseline in Iron, Total Iron Binding Capacity, and Creatinine at Week 16 and Week 24 |
2.08; 1.15; 0.24; 0.05; -20.33; 16.73 | — |
| SECONDARY Mean Change From Baseline in Transferrin and Albumin at Week 16 and Week 24 |
0.19; 0.09; 0.13; -0.22 | — |
| SECONDARY Mean Change From Baseline in Transferrin Saturation at Week 16 and Week 24 |
4.11; 2.41 | — |
| SECONDARY Mean Change From Baseline in C-Reactive Protein at Week 16 and Week 24 |
1.92; -1.43 | — |
| SECONDARY Mean Change From Baseline in Phosphate and Potassium at Week 16 and Week 24 |
0.04; 0.06; -0.04; -0.02 | — |
| SECONDARY Mean Change From Baseline in Weight at Week 16 and Week 24 |
0.5; 0.7 | — |
| SECONDARY Mean Change in From Baseline in Blood Pressure at Week 16 and Week 24 |
2.1; 2.4; 3.0; 2.2; -0.3; 1.7 | — |
| SECONDARY Number of Participants Taking Concomitant Medications |
13; 13; 7; 5; 4; 4 | — |
| SECONDARY Number of Participants With Any Adverse Events and Serious Adverse Events |
44; 13 | — |
| SECONDARY Number of Participants With Reports of Anti-erythropoietin Antibodies |
— | — |
| SECONDARY Number of Participants Who Received Red Blood Cell Transfusions During the Dose Titration Period and Efficacy Evaluation Period |
1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >= 18 years of age;
- chronic renal anemia;
- continuous stable iv or sc maintenance epoetin therapy during previous 4 weeks;
- 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 requiring hospitalization or interruption of epoetin treatment in previous 6 months;
- significant acute or chronic bleeding.
Data sourced from ClinicalTrials.gov (NCT00661505) 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.