drugset / Trial / NCT01183247
An Open, Single Centre, Randomised, Parallel Group Study to Investigate Three Different Immunosuppressive Regimens
RandomizedParallel-groupOpen-labelTreatment
Summary
An open, single center, randomised study to investigate three different immunosuppressive regimens for de novo renal transplant recipients: 1. st sirolimus / EC-MPS / tacrolimus regimen \- After 3 months a protocol biopsy is performed. If no rejection is detected the calcineurin inhibitor (tacrolimus) is withdrawn. 2. nd everolimus / EC-MPS / tacrolimus regimen \- After 3 months a protocol biopsy is performed. If no rejection is detected the calcineurin inhibitor (tacrolimus) is withdrawn. 3. rd tacrolimus / EC-MPS / prednisone regimen - After 3 months a protocol biopsy is performed. If no rejection is detected prednisone is withdrawn.
Timeline
- Start
- 2008-07
- Primary completion
- 2010-06
- Completion
- 2010-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Everolimus | Small molecule | — | — |
| Comparator | Prednisone | Other / unclassified | — | — |
| Comparator | Sirolimus | Small molecule | — | — |
Indications
No indication recorded.