Overview

Combination Immunosuppressive Therapy to Prevent Kidney Transplant Rejection in Adults

Status:
Completed
Trial end date:
2010-02-01
Target enrollment:
Participant gender:
Summary
Transplant rejection occurs when a patient's body does not recognize the new organ and attacks it. Patients who have kidney transplants must take drugs to prevent transplant rejection. Alemtuzumab is a man-made antibody used to treat certain blood disorders. The purpose of this study is to test the safety and effectiveness of using alemtuzumab in combination with two other drugs, sirolimus and tacrolimus, to prevent organ rejection after kidney transplantation. This study will also test whether this combination of medications will allow patients to eventually stop taking antirejection medications entirely. Study hypothesis: A new strategy of immunosuppression using alemtuzumab, tacrolimus, and sirolimus for human renal transplantation will permit a step-wise withdrawal from immunosuppressive drugs.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
University of Wisconsin, Madison
Collaborator:
Immune Tolerance Network (ITN)
Treatments:
Acetaminophen
Acyclovir
Alemtuzumab
Clotrimazole
Diphenhydramine
Everolimus
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Miconazole
Nystatin
Pentamidine
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Promethazine
Sirolimus
Tacrolimus
Trimethoprim
Trimethoprim, Sulfamethoxazole Drug Combination
Valganciclovir