Simultaneous Pancreas-kidney Transplantation With Campath Protocol

Summary

The purpose of this study is to determine and compare the efficacy of Campath-1H/Tacrolimus versus ATG/Tacrolimus/MMF therapy in conjunction with initial short-term steroids in Type 1-diabetic patients undergoing simultaneous pancreas-kidney allograft transplantation as well as to evaluate the safety of Campath-1H/Tacrolimus versus ATG/Tacrolimus/MMF in terms of drug-related complications and immunosuppression-associated complications.

Timeline

Start

2006-04

Primary completion

2011-02

Completion

2011-06

Publications

• Background Robertson P, Davis C, Larsen J, Stratta R, Sutherland DE; American Diabetes Association. Pancreas transplantation in type 1 diabetes. Diabetes Care. 2004 Jan;27 Suppl 1:S105. doi: 10.2337/diacare.27.2007.s105. No abstract available.
• Background Sutherland DE, Gruessner RW, Dunn DL, Matas AJ, Humar A, Kandaswamy R, Mauer SM, Kennedy WR, Goetz FC, Robertson RP, Gruessner AC, Najarian JS. Lessons learned from more than 1,000 pancreas transplants at a single institution. Ann Surg. 2001 Apr;233(4):463-501. doi: 10.1097/00000658-200104000-00003.
• Background Bechstein WO, Malaise J, Saudek F, Land W, Fernandez-Cruz L, Margreiter R, Nakache R, Secchi A, Vanrenterghem Y, Tyden G, Van Ophem D, Berney T, Boucek P, Landgraf R, Kahl A, Squifflet JP; EuroSPK Study Group. Efficacy and safety of tacrolimus compared with cyclosporine microemulsion in primary simultaneous pancreas-kidney transplantation: 1-year results of a large multicenter trial. Transplantation. 2004 Apr 27;77(8):1221-8. doi: 10.1097/01.tp.0000120865.96360.df.
• Background Burke GW 3rd, Kaufman DB, Millis JM, Gaber AO, Johnson CP, Sutherland DE, Punch JD, Kahan BD, Schweitzer E, Langnas A, Perkins J, Scandling J, Concepcion W, Stegall MD, Schulak JA, Gores PF, Benedetti E, Danovitch G, Henning AK, Bartucci MR, Smith S, Fitzsimmons WE. Prospective, randomized trial of the effect of antibody induction in simultaneous pancreas and kidney transplantation: three-year results. Transplantation. 2004 Apr 27;77(8):1269-75. doi: 10.1097/01.tp.0000123903.12311.36.
• Background Stratta RJ, Alloway RR, Lo A, Hodge E. Two-dose daclizumab regimen in simultaneous kidney-pancreas transplant recipients: primary endpoint analysis of a multicenter, randomized study. Transplantation. 2003 Apr 27;75(8):1260-6. doi: 10.1097/01.TP.0000062838.38351.2A.
• Background Kaufman DB, Leventhal JR, Gallon G, Axelrod D, Parker MA. Experience with Campath-1H induction therapy in simultaneous pancreas-kidney transplantation. Pancreas and Islet Transplant Association 2005, Geneva, Switzerland, [060]
• Background Thai NL, Khan A, Basu A, Tom K, Marcos A, Starzl TE, Shapiro R, Starzl TE. Pancreas transplantation under Campath-1H induction and tacrolimus monotherapy: preliminary results. The Joint Annual Meeting of the American Society of Transplant Surgeons and the American Society of Transplantation, 2005, Seattle, USA, [433]
• Background Gruessner RW, Kandaswamy R, Humar A, Gruessner AC, Sutherland DE. Calcineurin inhibitor- and steroid-free immunosuppression in pancreas-kidney and solitary pancreas transplantation. Transplantation. 2005 May 15;79(9):1184-9. doi: 10.1097/01.tp.0000161221.17627.8a.

Drugs

Indications

No indication recorded.