A World Leader in Kidney Transplants

Kidney Clinical Trials	Sponsor	Lead
The aim of this study is to evaluate the safety and efficacy of solid organ transplantation in people with HIV disease by conducting a prospective, multi-center cohort study of HIV-positive (+) patients who undergo kidney or liver transplantation. Our long-range goals are: 1) to provide patients and clinicians with information regarding the risks of transplantation, 2) to provide clinicians with information necessary to manage immunosuppressive and antiretroviral (ARV) medications together, and (3) to understand underlying mechanisms that explain patient outcomes so that clinical management may be adjusted to maximize outcomes. Our primary aims are: 1) To evaluate the impact of immunosuppression (IS) in HIV+ liver and kidney transplant recipients on patient survival and 2) To evaluate the impact of HIV infection and HAART on graft survival. The secondary aims are 1) to explore the impact of post-transplant immunosuppression on changes in CD4+ T cell counts and HIV-1 RNA levels; 2) To explore the impact of post-transplant immunosuppression on the host-response to viral co-pathogens, including hepatitis B and C, the human herpesviruses (CMV, EBV, HHV-6, HHV-8) and HPV; 3) To explore the impact of HIV infection on the alloimmune response and rejection rates; and 4) To explore the pharmacokinetic interactions between immunosuppressive agents and the hepatically metabolized antiretroviral agents.	National Institutes of Health	Humar, Abhinav
FTY720 combined with corticosteroids and full or reduced dose Neoral in de novo adult renal transplant recipients: a multicenter, partially blinded study of safety and efficacy	Novartis Pharmaceuticals	Kandaswamy, Raja
Simultaneous pancreas and kidney transplants involving Prograf and Rapamune in both limbs with randomization to 4 days vs. 6 mos. of prednisone	Wyeth-Ayerst	Kandaswamy, Raja
A prospective, randomized, open label, twenty-six week study of the efficacy and safety of converting kidney and liver transplant recipients with a tacrolimus-associated abnormal glucose metabolism to Neoral with C2 monitoring11		Lake, John
Patient Outcomes Registry for Transplant Effects on Life (PORTEL)	Fujisawa Healthcare	Matas, Arthur
Determination of DNA Polymorphisms Correlation with Transplant Outcome	Internal funds	Matas, Arthur & Oetting, William
Immune Parametes in a Steroid Avoidance Clinical Trial	National Institutes of Health	Matas, Arthur
C2 Levels In the First 6 Months After Transplantation	University of Minnesota Dept. of Surgery	Matas, Arthur
A Prospective, Randomized Study of Cyclosporine/MMF vs. Tacrolimus/Sirolimus in a Steroid Avoidance Protocol	National Institutes of Health & other support sponsors	Matas, Arthur
Optimizing Prograf (tacrolimus) Therapy in Maintenance Allografts (OPTIMA)	Fujisawa Healthcare	Matas, Arthur
Comprehensive Follow-up of Living Donors	National Institutes of Health	Matas, Arthur
Thymoglobulin Antibody Immunosuppression in Living Donor Recipients (TAILOR)		Matas, Arthur

More trials are in preparation or ongoing. Contact the Transplant Center for more information.