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. This study will test the safety and effectiveness of using a drug called Campath-1H in combination with two other drugs to prevent rejection after kidney transplantation. This study will also evaluate whether this combination of medications will allow patients to eventually stop taking antirejection medications entirely.

Condition	Treatment or Intervention	Phase
Kidney Transplantation	Drug: Campath-1H  Drug: sirolimus  Drug: tacrolimus  Procedure: kidney transplant	Phase I Phase II

Campath-1H is a recombinant DNA-derived humanized monoclonal antibody directed against the 21 to 28 kD cell surface glycoprotein CD52. CD52 is expressed on the surface of B and T lymphocytes, natural killer cells, monocytes, macrophages, and tissues of the male reproductive system.

The purpose of this study is to investigate the safety and efficacy of induction therapy with Campath-1H and tacrolimus, followed by sirolimus monotherapy, in renal transplant patients. The study will also evaluate this regimen’s potential to allow eventual discontinuation of long-term immunosuppressive therapy.

Adult patients undergoing kidney transplants will be eligible for this study. Participants will receive a total of five intravenous doses of Campath-1H during the first 2 weeks after the transplant. Study participants will also take tacrolimus (Prograf®) for at least 60 days after transplant and sirolimus (Rapamune®) for at least 12 months after transplant. Participants will be followed for up to 4 years after transplant.

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

• Kidney transplant with primary cadaveric or non-HLA-identical living donor kidney (0-3 HLA-antigen mismatch)
• Receiving only a kidney and no other organs
• Able to take medications by mouth
• Acceptable methods of contraception

Exclusion Criteria

• Pregnant

Wisconsin
      University of Wisconsin Department of Medicine, Madison,  Wisconsin,  53792-1735,  United States; Recruiting

Study chairs or principal investigators

Stuart Knechtle, MD,  Principal Investigator,  Immune Tolerance Network   

Study ID Numbers:  ITN013ST
Record last reviewed:  November 2004
Record first received:  March 1, 2004
ClinicalTrials.gov Identifier:  NCT00078559
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-08