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

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ClinicalTrials.gov Identifier: NCT00214201
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : September 12, 2012
Last Update Posted : October 3, 2012
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
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 or disease Intervention/treatment Phase
Primary Renal Transplant Drug: Calcineurin inhibitor withdrawal Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Campath-1H Induction to Allow Discontinuation of Calcineurin Inhibitors After Renal Transplantation
Study Start Date : May 2003
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Alemtuzumab
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Number of Participants With Biopsy Proven Rejection [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Serum Creatinine at 36 Months (End of Study) [ Time Frame: 36 months +/- 60 days ]

Other Outcome Measures:
  1. WBC [ Time Frame: 36 months +/- 60 days ]
    White Blood Cell count



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00214201


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

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00214201     History of Changes
Other Study ID Numbers: 2003-125
First Posted: September 21, 2005    Key Record Dates
Results First Posted: September 12, 2012
Last Update Posted: October 3, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Alemtuzumab
Calcineurin Inhibitors
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action