A randomized clinical trial and a pilot study are proposed. The objectives of the randomized clinical trial are to determine if antibodies to T cells and/or switching maintenance immunosuppression, when administered at the time of a biopsy-proven primary rejection episode, will significantly decrease the incidence of a second rejection and chronic rejection in kidney transplant recipients. The investigators will modify immunosuppression at the time of the first rejection episode by substituting OKT3 for steroid therapy and/or substituting mycophenolate for azathioprine or FK506 for Cyclosporine-A. The objective of the pilot study is to determine if early steroid withdrawal is tolerated by recipients of living, related donor transplants who are receiving Cyclosporine-A, mycophenolate, and Prednisone and have not had a rejection episode. Steroids will be withdrawn over a two week period three months after transplant. The primary endpoint will be the incidence of biopsy-proven rejection within six months of steroid withdrawal. If early steroid withdrawal is tolerated in this pilot study, a second pilot study will test the feasibility of withdrawing steroids at four weeks, and if this pilot is successful a third pilot will test the feasibility of administering steroids only during the perioperative period. If this series of pilot studies shows that steroids can be withdrawn with no increase in biopsy-proven rejection the consortium members plan to conduct a prospective randomized clinical trial. If any of the pilots fail, the consortium will proceed with a prospective randomized trial of the previous pilot.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01AI040166-03
Application #
2672826
Study Section
Special Emphasis Panel (ZAI1-KMC-I (20))
Project Start
1996-07-15
Project End
2001-06-30
Budget Start
1998-07-01
Budget End
1999-06-30
Support Year
3
Fiscal Year
1998
Total Cost
Indirect Cost
Name
University of Minnesota Twin Cities
Department
Surgery
Type
Schools of Medicine
DUNS #
168559177
City
Minneapolis
State
MN
Country
United States
Zip Code
55455
Roland, M E; Barin, B; Carlson, L et al. (2008) HIV-infected liver and kidney transplant recipients: 1- and 3-year outcomes. Am J Transplant 8:355-65
Stock, Peter G; Roland, Michelle E (2007) Evolving clinical strategies for transplantation in the HIV-positive recipient. Transplantation 84:563-71
Roland, Michelle E; Stock, Peter G (2006) Liver transplantation in HIV-infected recipients. Semin Liver Dis 26:273-84
Roland, Michelle E; Stock, Peter G (2006) Solid organ transplantation is a reality for patients with HIV infection. Curr HIV/AIDS Rep 3:132-8
Terrault, Norah A; Carter, Jonathan T; Carlson, Laurie et al. (2006) Outcome of patients with hepatitis B virus and human immunodeficiency virus infections referred for liver transplantation. Liver Transpl 12:801-7
Roland, Michelle E; Stock, Peter G (2003) Review of solid-organ transplantation in HIV-infected patients. Transplantation 75:425-9
Roland, Michelle E; Lo, Bernard; Braff, Jeffrey et al. (2003) Key clinical, ethical, and policy issues in the evaluation of the safety and effectiveness of solid organ transplantation in HIV-infected patients. Arch Intern Med 163:1773-8
Roland, Michelle E; Adey, Deborah; Carlson, Laurie L et al. (2003) Kidney and liver transplantation in HIV-infected patients: case presentations and review. AIDS Patient Care STDS 17:501-7
Stock, Peter G; Roland, Michelle E; Carlson, Laurie et al. (2003) Kidney and liver transplantation in human immunodeficiency virus-infected patients: a pilot safety and efficacy study. Transplantation 76:370-5
Matas, A J; Ramcharan, T; Paraskevas, S et al. (2001) Rapid discontinuation of steroids in living donor kidney transplantation: a pilot study. Am J Transplant 1:278-83