A Study Comparing Subcutaneous Mircera and Darbepoetin Alfa for Maintenance Treatment of Anemia in Kidney Transplant Recipients.
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
71 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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