Immunosuppression Impact on the Metabolic Control of Kidney Transplant With Pre-Existing Type 2 Diabetes (DM)

Summary

Protocol Title: Randomized open label study comparing the metabolic control of first Kidney Transplant recipients with Type 2 Diabetes Mellitus (DM) receiving either Prograf or Neoral as part of a ATG induction, prednisone free and blood monitored Cellcept immunosuppressive regimen. PURPOSE This is a single center medical research study to analyze post-transplant kidney recipients with pre-existing type 2 diabetes managed according to the recommended American Diabetes Association (ADA) guidelines. Prograf (Tac) and Neoral (CSA) are the two main medications to prevent rejection after transplantation. However, they may contribute to poorer diabetes control. The purpose of the study is to compare the effects of Prograf and Neoral on the control of Diabetes after kidney transplantation. In addition, all participants in this study will receive Thymoglobulin (anti-lymphocyte globulin) at the time of transplantation instead of long term prednisone (steroids).

Timeline

Start

2005-06

Primary completion

2014-10

Completion

2014-10

Publications

• Background Weir MR, Fink JC. Risk for posttransplant Diabetes mellitus with current immunosuppressive medications. Am J Kidney Dis. 1999 Jul;34(1):1-13. doi: 10.1016/s0272-6386(99)70101-0.
• Background Sarwal MM, Yorgin PD, Alexander S, Millan MT, Belson A, Belanger N, Granucci L, Major C, Costaglio C, Sanchez J, Orlandi P, Salvatierra O Jr. Promising early outcomes with a novel, complete steroid avoidance immunosuppression protocol in pediatric renal transplantation. Transplantation. 2001 Jul 15;72(1):13-21. doi: 10.1097/00007890-200107150-00006.
• Background Rigatto C. Clinical epidemiology of cardiac disease in renal transplant recipients. Semin Dial. 2003 Mar-Apr;16(2):106-10. doi: 10.1046/j.1525-139x.2003.16026.x.
• Background Hamar P, Muller V, Kohnle M, Witzke O, Albrecht KH, Philipp T, Heemann U. Metabolic factors have a major impact on kidney allograft survival. Transplantation. 1997 Oct 27;64(8):1135-9. doi: 10.1097/00007890-199710270-00009.
• Background Maes BD, Kuypers D, Messiaen T, Evenepoel P, Mathieu C, Coosemans W, Pirenne J, Vanrenterghem YF. Posttransplantation diabetes mellitus in FK-506-treated renal transplant recipients: analysis of incidence and risk factors. Transplantation. 2001 Nov 27;72(10):1655-61. doi: 10.1097/00007890-200111270-00014.
• Background Revanur VK, Jardine AG, Kingsmore DB, Jaques BC, Hamilton DH, Jindal RM. Influence of diabetes mellitus on patient and graft survival in recipients of kidney transplantation. Clin Transplant. 2001 Apr;15(2):89-94. doi: 10.1034/j.1399-0012.2001.150202.x.
• Background Gerber JC, Stewart DL. Prevention and control of hypertension and diabetes in an underserved population through community outreach and disease management: a plan of action. J Assoc Acad Minor Phys. 1998;9(3):48-52.
• Background Navasa M, Bustamante J, Marroni C, Gonzalez E, Andreu H, Esmatjes E, Garcia-Valdecasas JC, Grande L, Cirera I, Rimola A, Rodes J. Diabetes mellitus after liver transplantation: prevalence and predictive factors. J Hepatol. 1996 Jul;25(1):64-71. doi: 10.1016/s0168-8278(96)80329-1.

Drugs

Indications