Campath-1H Induction to Allow Discontinuation of Calcineurin Inhibitors After Renal Transplantation

This study has been completed.
Information provided by (Responsible Party):
University of Wisconsin, Madison Identifier:
First received: September 13, 2005
Last updated: September 21, 2012
Last verified: September 2012
The purpose of this study is to determine whether Campath-1H induction therapy and the associated lymphocyte depletion will permit long-term, rejection free renal allograft function in the absence of maintenance calcineurin inhibitor (CI) therapy.

Condition Intervention
Primary Renal Transplant
Drug: Calcineurin inhibitor withdrawal

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Campath-1H Induction to Allow Discontinuation of Calcineurin Inhibitors After Renal Transplantation

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Number of Participants With Biopsy Proven Rejection [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Serum Creatinine at 36 Months (End of Study) [ Time Frame: 36 months +/- 60 days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • WBC [ Time Frame: 36 months +/- 60 days ] [ Designated as safety issue: No ]
    White Blood Cell count

Enrollment: 40
Study Start Date: May 2003
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Standard of Care CNI immunosuppression
Experimental: 2
Calcineurin inhibitor withdrawal
Drug: Calcineurin inhibitor withdrawal
stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • received a renal transplant, induction with Campath-1H, and at least 2 months of calcineurin inhibitor therapy, CellCept, and prednisone.

Exclusion Criteria:

  • Recipients of HLA-identical living-donor renal transplants;
  • PRA value >20% within 30 days of transplant;
  • GFR <40ml/min;
  • multi-organ transplant;
  Contacts and Locations
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Please refer to this study by its identifier: NCT00214201

United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: Stuart Knechtle, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison Identifier: NCT00214201     History of Changes
Other Study ID Numbers: 2003-125 
Study First Received: September 13, 2005
Results First Received: August 13, 2012
Last Updated: September 21, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses processed this record on February 04, 2016