Phase 2
Completed N=65
A Study of Mircera in Anemic Patients With Chronic Kidney Disease Not Yet on Dialysis.
Source: ClinicalTrials.gov NCT00048048 ↗Enrolled (actual)
65
Serious AEs
49.2%
Results posted
Jan 2018
Primary outcomePrimary: The Change in Hemoglobin Over Time Between Baseline and End of Initial Treatment Based on Individual Regression Slopes — 0.48; 1.08; 1.34; 0.17 gram/deciliter (g/dL)
Summary
This study will evaluate the efficacy and safety of different subcutaneous starting doses and dosing frequencies of Mircera in anemic patients with chronic kidney disease not yet on dialysis. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Change in Hemoglobin Over Time Between Baseline and End of Initial Treatment Based on Individual Regression Slopes |
0.48; 1.08; 1.34; 0.17; 0.27; 2.17 | — |
| SECONDARY Hematocrit Levels at End of Initial Treatment Under Constant Dosing Regimen |
31.10; 39.10; 36.95; 28.40; 34.70; 40.50 | — |
| SECONDARY Reticulocyte Count at End of Initial Treatment Under Constant Dosing Regimen |
71.80; 46.30; 44.70; 51.80; 72.80; 59.20 | — |
| SECONDARY Number of Participants With Any Serious Adverse Events and Any Adverse Events |
11; 9; 12; 22; 21; 22 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes Over Time |
0; 1; 0; 0; 0; 3 | — |
| SECONDARY Heart Rate Over Time |
65.6; 68.4; 75.4 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure |
2; 5; 6; 6; 2; -3 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients >=18 years of age;
- chronic renal anemia;
- not receiving renal replacement therapy.
Exclusion Criteria
- women who are pregnant, breastfeeding or using unreliable birth control methods;
- administration of any investigational drug within 30 days preceding the screening visit and during the run-in period.
Data sourced from ClinicalTrials.gov (NCT00048048). 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.