drugset / Trial / NCT00452361
Study Evaluating of Calcineurin Inhibitors Versus Sirolimus in Renal Allograft Recipient
RandomizedParallel-groupOpen-labelTreatment
Summary
This study will evaluate whether conversion from cyclosporine, a calcineurin inhibitor (CI) to sirolimus (SRL) results in improved long-term renal function without a negative impact on safety or immunosuppressive efficacy, and to further examine the potential of SRL to reduce the severity and/or progression of chronic allograft nephropathy (CAN).
Timeline
- Start
- 2007-04
- Primary completion
- 2008-08
- Completion
- 2008-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclosporine | Peptide | — | — |
| Background | Sirolimus | Small molecule | — | — |
| Comparator | Tacrolimus | Small molecule | — | — |
| Background | AZA | Unknown | 50 mg | — |
| Background | AZA | Unknown | 75 mg | — |
| Background | MMF | Unknown | 500 mg | — |
| Background | MMF | Unknown | 1500 mg | — |
| Background | MPS | Unknown | 360 mg | — |
| Background | MPS | Unknown | 1080 mg | — |
| Background | Prednisolone | Other / unclassified | 2.5 mg | — |
| Background | Prednisolone | Other / unclassified | 15 mg | — |
| Background | Prednisone | Other / unclassified | 2.5 mg | — |
| Background | Prednisone | Other / unclassified | 15 mg | — |
| Background | Sirolimus | Small molecule | 2 mg | — |
| Background | Sirolimus | Small molecule | 12 mg | — |
Indications
No indication recorded.