drugset / Trial / NCT00267189
RESCUE Study - Everolimus in Liver Transplantation Recipients With Renal Insufficiency
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the study is to assess the effect of everolimus initiation together with reduction or discontinuation of calcineurin inhibitor (CNI) on renal function in maintenance liver transplant recipients with CNI-related renal impairment, while maintaining efficacy.
Timeline
- Start
- 2005-11
- Primary completion
- 2007-11
- Completion
- 2007-11
Publications
- Results De Simone P, Metselaar HJ, Fischer L, Dumortier J, Boudjema K, Hardwigsen J, Rostaing L, De Carlis L, Saliba F, Nevens F. Conversion from a calcineurin inhibitor to everolimus therapy in maintenance liver transplant recipients: a prospective, randomized, multicenter trial. Liver Transpl. 2009 Oct;15(10):1262-9. doi: 10.1002/lt.21827.
- Schrader J, Sterneck M, Klose H, Lohse AW, Nashan B, Fischer L. Everolimus-induced pneumonitis: report of the first case in a liver transplant recipient and review of treatment options. Transpl Int. 2010 Jan;23(1):110-3. doi: 10.1111/j.1432-2277.2009.00900.x. Epub 2009 May 29. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclosporine | Peptide | — | — |
| Comparator | Everolimus | Small molecule | 1.5 mg | — |
| Subject | Tacrolimus | Small molecule | — | — |
| Background | Azathioprine | Small molecule | — | — |
| Background | Mycophenolate acid | Unknown | — | — |
Indications
No indication recorded.