Phase 3
Completed N=75
A Study of Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Predialysis Patients Not Treated With ESA.
Source: ClinicalTrials.gov NCT00661388 ↗Enrolled (actual)
75
Serious AEs
32.0%
Results posted
Jul 2016
Primary outcomePrimary: Mean Change in Hb Concentration Between Baseline and the Efficacy Evaluation Period — 1.99 g/dL
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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 methoxy polyethylene glycol-epoetin beta (Mircera) for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with erythropoietin stimulating agents (ESA). Eligible patients will receive monthly subcutaneous injections of Mircera at an initial recommended dose of 1.2 micrograms/kg. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Hb Concentration Between Baseline and the Efficacy Evaluation Period |
1.99 | — |
| SECONDARY Mean Time to Achievement of Response During the EEP |
24.2 | — |
| SECONDARY The Percentage of Participants Whose Hb Concentrations Remained Within the Target Range of 10.0- 12.0 g/dLThroughout the EEP |
43.9 | — |
| SECONDARY Mean Time Spent by Participants in the Target Range of 10.0- 12.0 g/dL During the EEP |
40.6 | — |
| SECONDARY Percentage of Participants Requiring Dose Adjustments During Dose Titration Period and EEP |
85.4; 14.6; 24.4; 46.3; 56.1; 17.1 | — |
| SECONDARY Number of Participants Who Received Red Blood Cell Transfusions During the Study Period |
2; 1; 1 | — |
| SECONDARY Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events |
58; 24 | — |
| SECONDARY Mean Change From Baseline in Hb Concentration Over Time |
1.50; 2.03; 1.86; 1.85; 1.84; 1.59 | — |
| SECONDARY Mean Change From Baseline in Hematocrit Level Over Time |
0.05; 0.06; 0.06; 0.06; 0.06; 0.05 | — |
| SECONDARY Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume Over Time |
0.17; -1.31; -1.10; -0.34; 0.97 | — |
| SECONDARY Mean Change From Baseline in White Blood Cells and Platelets Concentrations Over Time |
0.04; 0.06; 0.12; 0.01; -0.13; 0.04 | — |
| SECONDARY Mean Change From Baseline in Albumin Concentration Over Time |
0.45; 0.06; -0.30; 0.24; -0.57; -0.61 | — |
| SECONDARY Mean Change From Baseline in C-Reactive Protein Concentration Over Time |
-1.82; -1.80; 0.03; -0.33; -1.49; 0.86 | — |
| SECONDARY Mean Change From Baseline in Phosphate and Potassium Concentrations Over Time |
0.11; 0.06; 0.07; 0.13; 0.06; 0.07 | — |
| SECONDARY Mean Change From Baseline in Total Iron Binding Capacity and Iron Concentrations Over Time |
0.09; -0.21; 0.34; 0.15; 2.24; -2.02 | — |
| SECONDARY Mean Change From Baseline in Creatinine Concentration Over Time |
23.87; 123.67; -8.40; 17.7 | — |
| SECONDARY Mean Change From Baseline in Ferritin Concentration Over Time |
-95.15; -82.82; -71.98; -78.45; -59.94; -43.46 | — |
| SECONDARY Mean Change From Baseline in Transferrin Saturation Over Time |
-5.91; 1.69; 1.42; 2.52; 3.52; 5.32 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- chronic renal anemia;
- predialysis stage;
- no ESA therapy during previous 3 months.
Exclusion Criteria
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension requiring hospitalization in previous 6 months;
- significant acute or chronic bleeding.
Data sourced from ClinicalTrials.gov (NCT00661388). 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.