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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00214201 |
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Date of registration:
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13/09/2005 |
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Primary sponsor: |
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Public title:
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Campath-1H Induction to Allow Discontinuation of Calcineurin Inhibitors After Renal Transplantation
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Scientific title:
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Campath-1H Induction to Allow Discontinuation of Calcineurin Inhibitors After Renal Transplantation |
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Date of first enrolment:
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May 2003 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00214201 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Stuart Knechtle, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Wisconsin, Madison |
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Key inclusion & exclusion criteria
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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;
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Primary Renal Transplant
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Intervention(s)
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Drug: Calcineurin inhibitor withdrawal
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Primary Outcome(s)
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Number of Participants With Biopsy Proven Rejection
[Time Frame: 3 years]
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Secondary Outcome(s)
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Serum Creatinine at 36 Months (End of Study)
[Time Frame: 36 months +/- 60 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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