At a glance
ClinicalIndex Comparison Record- ✓Kidney transplantation recipient
- ✓Donor must be at least 60 years old
- ✕Current systemic infection
- ✕Unstable angina or treatment for serious arrhythmia
- ✕Cancer within the previous 5 years
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Open-Label Study Comparing the Efficacy and Safety of Sirolimus Combined With Daclizumab, Mycophenolate and Corticosteroids vs Cyclosporine, Mycophenolate and Corticosteroids in Renal Allograft Recipients Receiving Kidneys From Older Donors
In Brief
A Phase 3 clinical trial evaluating sirolimus, cyclosporine, and 3 other interventions for Graft vs Host Disease and Kidney Transplantation. Completed, enrolled 61 participants across 3 sites in 2 countries.
Detailed Summary
The purpose of this study is to compare the kidney function in patients who have received a transplanted kidney and were treated with the combination of sirolimus, daclizumab, mycophenolate and corticosteroids versus transplanted patients treated with cyclosporine, mycophenolate and corticosteroids.
Study Details
Timeline
Interventions
15 mg loading dose, followed by 5 mg/day to achieve target trough levels of 10-15 ng/mL at months 1-6, then 8-12 ng/mL at months 7-12
Initial dose of 10 mg/kg/day, then twice daily to achieve target trough levels of 300-400 ng/mL at weeks 0-4; 200-300 ng/mL at months 1-2; 150-250 ng/mL at months 2-3; 100-200 ng/mL at months 3-6; 75-150 ng/mL months 6-12
1 g twice daily; may be reduced to 750 mg BID for adverse events, or to 500 mg BID for persisting adverse events
As per center practice. By day 8 prednisolone tapered to 20 mg/day; by day 30 to 15 mg/day; by day 60 to 10 mg/day; after 4 to 6 months to 5-7.5 mg/day
IV: 1 mg/kg to a maximum of 100 mg/dose. 5 doses at 2, 4, 6, and 8 weeks after transplantation