We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00214201
First Posted: September 21, 2005
Last Update Posted: October 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Wisconsin, Madison
September 13, 2005
September 21, 2005
August 13, 2012
September 12, 2012
October 3, 2012
May 2003
May 2009   (Final data collection date for primary outcome measure)
Number of Participants With Biopsy Proven Rejection [ Time Frame: 3 years ]
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 ]
Not Provided
WBC [ Time Frame: 36 months +/- 60 days ]
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
Intervention Model: Parallel Assignment
Masking: None (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;
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00214201
2003-125
Yes
Not Provided
Not Provided
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
To Top