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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00214201
First received: September 13, 2005
Last updated: September 21, 2012
Last verified: September 2012

September 13, 2005
September 21, 2012
May 2003
May 2009   (final data collection date for primary outcome measure)
Number of Participants With Biopsy Proven Rejection [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
calcineurin inhibitor therapy
Complete list of historical versions of study NCT00214201 on ClinicalTrials.gov Archive Site
Serum Creatinine at 36 Months (End of Study) [ Time Frame: 36 months +/- 60 days ] [ Designated as safety issue: No ]
Not Provided
WBC [ Time Frame: 36 months +/- 60 days ] [ Designated as safety issue: No ]
White Blood Cell count
Not Provided
 
Campath-1H Induction to Allow Discontinuation of Calcineurin Inhibitors After Renal Transplantation
Campath-1H Induction to Allow Discontinuation of Calcineurin Inhibitors After Renal Transplantation

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Primary Renal Transplant
Drug: Calcineurin inhibitor withdrawal
stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
  • No Intervention: 1
    Standard of Care CNI immunosuppression
  • Experimental: 2
    Calcineurin inhibitor withdrawal
    Intervention: Drug: Calcineurin inhibitor withdrawal
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 2009
May 2009   (final data collection date for primary outcome measure)

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;
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00214201
2003-125
Yes
University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Principal Investigator: Stuart Knechtle, MD University of Wisconsin, Madison
University of Wisconsin, Madison
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP