University of Wisconsin
Madison, Wisconsin, 53792, United States
Completed
NCT Number: NCT00214201
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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;
Treatment and study plan
Calcineurin inhibitor withdrawal
Drugstopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
Primary outcomes
-
Number of Participants With Biopsy Proven Rejection
Time frame: 3 years
Secondary outcomes
-
Serum Creatinine at 36 Months (End of Study)
Time frame: 36 months +/- 60 days
Other outcomes
-
WBC
Time frame: 36 months +/- 60 days
White Blood Cell count
Sponsors and collaborators
Lead sponsor
University of Wisconsin, Madison
Other
Registry information
Important dates
- Study start
- 2003
- Primary completion
- 2009
- Study completion
- 2009
- First posted
- Sep 21, 2005
- Registry last updated
- Oct 3, 2012
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.