drugset / Trial / NCT01469884
Effect of Switching to Certican® in Viremia of Hepatitis C Virus in Adult Renal Allograft Recipients
Phase 4
Completed
30 enrolled
Irmandade Santa Casa de Misericórdia de Porto Alegre
Novartis · collab
RandomizedParallel-groupOpen-labelSupportive care
Summary
Compare the viral load of hepatitis c virus in patients converted to certican versus patients who are maintained on calcineurin inhibitor.
Timeline
- Start
- 2011-11
- Primary completion
- 2015-04
- Completion
- 2015-04
Publications
- Background Benedetto, F. D.; Sandro, S. D.; Ballarin, R.; Guaraldi, G.; Gerunda, G. E. Rapamycin and HIV Replication in Liver Transplant Recipients. Transplantation, 9, 1040, 2010.
- Background Boletis JN, Iniotaki-Theodoraki A, Psichogiou M, Stamatiadis DN, Viglis JV, Kostakis A, Stavropoulos-Giokas C. Immune status in renal transplant recipients with hepatitis C virus infection. Transplant Proc. 2002 Dec;34(8):3205-8. doi: 10.1016/s0041-1345(02)03656-4. No abstract available.
- Background Gallego R, Henriquez F, Oliva E, Camacho R, Hernandez R, Hortal L, Sablon N, Quintana B, Santana R, Gonzalez F, Palop L, Vega N. Switching to sirolimus in renal transplant recipients with hepatitis C virus: a safe option. Transplant Proc. 2009 Jul-Aug;41(6):2334-6. doi: 10.1016/j.transproceed.2009.06.064.
- Background Ingsathit A, Thakkinstian A, Kantachuvesiri S, Sumethkul V. Different impacts of hepatitis B virus and hepatitis C virus on the outcome of kidney transplantation. Transplant Proc. 2007 Jun;39(5):1424-8. doi: 10.1016/j.transproceed.2007.02.068.
- Background Mas, V.; Alvarellos, T.; Chiurchiu, C.; Camps, D.; Massari, P.; Boccardo, G. Hepatitis C Virus Infection After Renal Transplantation: Viral Load and Outcome. Transplantation Proceedings, 33, 1791-1793, 2001. Ridruejo, E.; Cusumano, A.; Diaz, C.; Dávalos Michel. M.; Jost, L.; Jost, L.; Soler Pujol, G.; Mandó, O. G.; Vilches, A. Hepatitis C Virus Infection and Outcome of Renal Transplantation. Transplantation Proceedings , 39, 3127-3130, 2007.
- Background Meier-Kriesche HU, Ojo AO, Hanson JA, Kaplan B. Hepatitis C antibody status and outcomes in renal transplant recipients. Transplantation. 2001 Jul 27;72(2):241-4. doi: 10.1097/00007890-200107270-00013.
- Background Wagner D, Kniepeiss D, Schaffellner S, Jakoby E, Mueller H, Fahrleitner-Pammer A, Stiegler P, Tscheliessnigg KH, Iberer F. Sirolimus has a potential to influent viral recurrence in HCV positive liver transplant candidates. Int Immunopharmacol. 2010 Aug;10(8):990-3. doi: 10.1016/j.intimp.2010.05.006. Epub 2010 May 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclosporine | Peptide | — | — |
| Subject | Everolimus | Small molecule | 3 mg | — |
| Comparator | Tacrolimus | Small molecule | — | — |