drugset / Trial / NCT00251004
Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study was to compare the safety and efficacy of three immunosuppressive treatment regimens following a kidney transplant.
Timeline
- Start
- 2005-10
- Primary completion
- 2009-08
- Completion
- 2009-10
Publications
- Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.
- Cibrik D, Silva HT Jr, Vathsala A, Lackova E, Cornu-Artis C, Walker RG, Wang Z, Zibari GB, Shihab F, Kim YS. Randomized trial of everolimus-facilitated calcineurin inhibitor minimization over 24 months in renal transplantation. Transplantation. 2013 Apr 15;95(7):933-42. doi: 10.1097/TP.0b013e3182848e03.
- Shihab FS, Cibrik D, Chan L, Kim YS, Carmellini M, Walker R, Zibari G, Pattison J, Cornu-Artis C, Wang Z, Tedesco-Silva H Jr. Association of clinical events with everolimus exposure in kidney transplant patients receiving reduced cyclosporine. Clin Transplant. 2013 Mar-Apr;27(2):217-26. doi: 10.1111/ctr.12045. Epub 2012 Dec 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclosporine | Peptide | — | — |
| Subject | Everolimus | Small molecule | 1.5 mg | Oral |
| Subject | Everolimus | Small molecule | 3 mg | Oral |
| Comparator | mycophenolic acid | Small molecule | 1.44 g | Oral |
| Background | Basiliximab | Monoclonal antibody | 20 mg | Intravenous |