Phase 3
Completed N=71
A Study Comparing Subcutaneous Mircera and Darbepoetin Alfa for Maintenance Treatment of Anemia in Kidney Transplant Recipients.
Source: ClinicalTrials.gov NCT00605345 ↗Enrolled (actual)
71
Serious AEs
16.9%
Results posted
Aug 2016
Primary outcomePrimary: The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range — 64.29; 57.14 percentage of participants — p=0.5947
Summary
This two arm study will compare the efficacy and safety of subcutaneous Mircera versus darbepoetin alfa for the maintenance of hemoglobin levels in kidney transplant recipients with chronic renal anemia. Patients currently receiving maintenance treatment with darbepoetin alfa will be randomized either to receive 4-weekly injections of Mircera with a starting dose (120, 200 or 360 micrograms subcutaneously) derived from the dose of darbepoetin alfa they were receiving in the 2 weeks preceding study start, or to stay on 2-weekly darbepoetin alfa therapy. 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 The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range |
64.29; 57.14 | 0.5947 |
| SECONDARY Mean Change in Hb Concentration From Baseline to Efficacy Evaluation Period (EEP) |
0.08; 0.05 | — |
| SECONDARY Percentage of Participants Maintaining Hb Concentration in 10-12 g/dL Range Throughout the Efficacy Evaluation Period (EEP) |
71.7; 64.0 | — |
| SECONDARY Mean Time Spent in 10-12g/dL Range During the Efficacy Evaluation Period (EEP) |
57.0; 50.5 | — |
| SECONDARY Percentage of Participants Needing Dose Adjustments |
73.9; 56.0; 33.3; 20.8 | — |
| SECONDARY Incidence of RBC Transfusions |
1; 2 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, > or = 18 years of age;
- kidney transplant recipients with stage 3 or stage 4 chronic kidney disease;
- functioning graft of > 6 months and < 10 years after kidney transplantation, with no signs of acute rejection;
- stable maintenance subcutaneous darbepoetin alfa therapy every 2 weeks.
Exclusion Criteria
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension;
- significant acute or chronic bleeding;
- need for dialysis therapy expected in next 6 months.
Data sourced from ClinicalTrials.gov (NCT00605345). 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.