Mycophenolate Mofetil Immunosuppression Without/With Reduced Dose Calcineurin Inhibitor Long After Liver Transplantation

Summary

The purpose of the study is to assess the safety and efficacy of mycophenolate mofetil alone, or with reduced dose cyclosporine (CsA) or tacrolimus, for immunosuppression long-term after liver transplantation, in an attempt to reduce the potential side effects from using cyclosporine or tacrolimus.

Timeline

Start

2006-08

Primary completion

2009-06

Completion

2009-06

Publications

• Background Reich DJ, Clavien PA, Hodge EE; MMF Renal Dysfunction after Liver Transplantation Working Group. Mycophenolate mofetil for renal dysfunction in liver transplant recipients on cyclosporine or tacrolimus: randomized, prospective, multicenter pilot study results. Transplantation. 2005 Jul 15;80(1):18-25. doi: 10.1097/01.tp.0000165118.00988.d7.
• Background Reich D, Rothstein K, Manzarbeitia C, Munoz S. Common medical diseases after liver transplantation. Semin Gastrointest Dis. 1998 Jul;9(3):110-25.
• Background Mazariegos GV, Reyes J, Marino IR, Demetris AJ, Flynn B, Irish W, McMichael J, Fung JJ, Starzl TE. Weaning of immunosuppression in liver transplant recipients. Transplantation. 1997 Jan 27;63(2):243-9. doi: 10.1097/00007890-199701270-00012.
• Background McDiarmid SV, Farmer DA, Goldstein LI, Martin P, Vargas J, Tipton JR, Simmons F, Busuttil RW. A randomized prospective trial of steroid withdrawal after liver transplantation. Transplantation. 1995 Dec 27;60(12):1443-50. doi: 10.1097/00007890-199560120-00013.
• Background Fraser GM, Grammoustianos K, Reddy J, Rolles K, Davidson B, Burroughs AK. Long-term immunosuppression without corticosteroids after orthotopic liver transplantation: a positive therapeutic aim. Liver Transpl Surg. 1996 Nov;2(6):411-7. doi: 10.1002/lt.500020602.
• Background Stegall MD, Everson GT, Schroter G, Karrer F, Bilir B, Sternberg T, Shrestha R, Wachs M, Kam I. Prednisone withdrawal late after adult liver transplantation reduces diabetes, hypertension, and hypercholesterolemia without causing graft loss. Hepatology. 1997 Jan;25(1):173-7. doi: 10.1002/hep.510250132.
• Background Hodge EE, Reich DJ, Clavien PA, Kim-Schluger L. Use of mycophenolate mofetil in liver transplant recipients experiencing renal dysfunction on cyclosporine or tacrolimus-randomized, prospective, multicenter study results. Transplant Proc. 2002 Aug;34(5):1546-7. doi: 10.1016/s0041-1345(02)03014-2. No abstract available.
• Background Raimondo ML, Dagher L, Papatheodoridis GV, Rolando N, Patch DW, Davidson BR, Rolles K, Burroughs AK. Long-term mycophenolate mofetil monotherapy in combination with calcineurin inhibitors for chronic renal dysfunction after liver transplantation. Transplantation. 2003 Jan 27;75(2):186-90. doi: 10.1097/01.TP.0000041702.31262.CD.
• Background Schlitt HJ, Barkmann A, Boker KH, Schmidt HH, Emmanouilidis N, Rosenau J, Bahr MJ, Tusch G, Manns MP, Nashan B, Klempnauer J. Replacement of calcineurin inhibitors with mycophenolate mofetil in liver-transplant patients with renal dysfunction: a randomised controlled study. Lancet. 2001 Feb 24;357(9256):587-91. doi: 10.1016/s0140-6736(00)04055-1.
• Background Herrero JI, Quiroga J, Sangro B, Girala M, Gomez-Manero N, Pardo F, Alvarez-Cienfuegos J, Prieto J. Conversion of liver transplant recipients on cyclosporine with renal impairment to mycophenolate mofetil. Liver Transpl Surg. 1999 Sep;5(5):414-20. doi: 10.1002/lt.500050513.
• Background Stewart SF, Hudson M, Talbot D, Manas D, Day CP. Mycophenolate mofetil monotherapy in liver transplantation. Lancet. 2001 Feb 24;357(9256):609-10. doi: 10.1016/s0140-6736(00)04065-4.
• Background Munoz SJ, Rothstein KD, Reich D, Manzarbeitia C. Long-term care of the liver transplant recipient. Clin Liver Dis. 2000 Aug;4(3):691-710. doi: 10.1016/s1089-3261(05)70133-1.
• Background Wiesner R, Rabkin J, Klintmalm G, McDiarmid S, Langnas A, Punch J, McMaster P, Kalayoglu M, Levy G, Freeman R, Bismuth H, Neuhaus P, Mamelok R, Wang W. A randomized double-blind comparative study of mycophenolate mofetil and azathioprine in combination with cyclosporine and corticosteroids in primary liver transplant recipients. Liver Transpl. 2001 May;7(5):442-50. doi: 10.1053/jlts.2001.23356.
• Background Shaw LM, Korecka M, Venkataramanan R, Goldberg L, Bloom R, Brayman KL. Mycophenolic acid pharmacodynamics and pharmacokinetics provide a basis for rational monitoring strategies. Am J Transplant. 2003 May;3(5):534-42. doi: 10.1034/j.1600-6143.2003.00079.x. No abstract available.

Drugs

Indications