Combination Immunosuppressive Therapy to Prevent Kidney Transplant Rejection in Adults

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria

• Kidney transplant with primary cadaveric or non-Human Leukocyte Antigen (HLA)-identical living donor kidney (0-3 HLA-antigen mismatch)

• Receiving only a kidney and no other organs

• Able to take medications by mouth

• Willing to use acceptable methods of contraception

Exclusion Criteria

• Received HLA-identical living-donor kidney transplant

• HLA-antigen mismatch greater than 3

• Panel reactive antibody (PRA) value greater than 10% at any time prior to enrollment

• Received a non-heart-beating donor allograft

• Received a kidney from a donor who is greater than 60 years of age

• End-stage Renal Disease (ESRD) due to Focal Segmental Glomulerosclerosis (FSGS)

• Previous kidney transplant

• Received multiorgan transplant

• Concomitant systemic corticosteroid therapy for other medical diseases

• Known hypersensitivity to alemtuzumab, tacrolimus, methylprednisolone, or sirolimus

• Human Immunodeficiency Virus (HIV) infected

• Hepatitis C virus infected

• Positive for hepatitis B surface antigen

• Received dual or en-bloc pediatric kidneys

• Anti-human Globulin (AHG) or T cell crossmatch positive

• Investigational drug within 6 weeks of study entry

• Known clinically significant cardiovascular or cerebrovascular disease

• Previous or current history of cancer or lymphoma. Patients with adequately treated basal or squamous cell skin carcinoma are not excluded.

• Clinically significant coagulopathy or a requirement for chronic anti-coagulation therapy precluding biopsy

• Cytomegalovirus (CMV)-negative recipient, if received kidney is from a CMV-positive donor

• History of a psychological illness or condition that, in the opinion of the investigator, may interfere with the study

• Graves disease. Patients who have been previously adequately treated with radioiodine ablative therapy are not excluded.

• Active systemic infections

• Platelets less than 100,000 cells/mm^3 at study entry

• Pregnant or breastfeeding