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.

Study hypothesis: A new strategy of immunosuppression using Campath-1H, tacrolimus, and sirolimus for human renal transplantation will permit a step-wise withdrawal from immunosuppressive drugs.

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

Further Study Details: 

Primary Outcomes: Incidence rate of acute rejection in all enrolled participants
Secondary Outcomes: Rate of acute rejection in all enrolled participants following sirolimus withdrawal; acute rejection rate between initiation of sirolimus withdrawal and end of study; time from transplantation to acute rejection in participants for whom sirolimus withdrawal is not initiated; time from transplantation to acute rejection in participants for whom acute rejection occurred in the 1 year post-transplant period; time from transplantation to acute rejection in participants for whom sirolimus withdrawal has been initiated; incidence rate of death, graft loss, or severe acute rejection stratified by sirolimus withdrawal status; incidence and severity of acute rejections, stratified by sirolimus withdrawal status; proportion of participants requiring anti-lymphocyte therapy (OKT3, ATG) for an acute rejection, stratified by sirolimus withdrawal status; safety, including incidence of post-transplant infections, malignancies, and side effects associated with conventional immunosuppression; renal function as measured by serum creatinine, stratified by sirolimus withdrawal status
Expected Total Enrollment:  10

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 - Madison, Department of Surgery, 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:  March 2005
Last Updated:  March 9, 2005
Record first received:  March 1, 2004
ClinicalTrials.gov Identifier:  NCT00078559
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08