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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: |
NCT00217152 |
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Date of registration:
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20/09/2005 |
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Primary sponsor: |
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Public title:
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A Kidney Transplant Study to Look at the Effects of Taking Fixed Doses of CellCept Versus Taking Doses of CellCept Based on the Concentration of CellCept in the Blood When Taking Full or Reduced Dose Calcineurin Inhibitors
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Scientific title:
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An Open Label, Prospective, Randomized, Controlled, Multicenter Study Assessing Fixed Dose vs. Concentration Controlled CellCept Regimens for Patients Following a Single Organ Renal Transplantation in Combination With Full Dose and Reduced Dose Calcineurin Inhibitors |
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Date of first enrolment:
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March 2005 |
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Target sample size:
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12 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00217152 |
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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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Mark D. Stegall, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Participants must be between 18 and 70 years of age and should be receiving their
first or second kidney transplant.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Delayed Graft Function
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Kidney Transplantation
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Intervention(s)
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Drug: CellCept
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Primary Outcome(s)
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Assessment of renal function
[Time Frame: 12 months post randomization]
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Treatment failure defined as a biopsy proven acute rejection, graft loss, death, or lost to follow-up
[Time Frame: during the first 12 months following randomization]
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Secondary Outcome(s)
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The proportion of patients experiencing biopsy proven acute rejections
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The proportion of patients treated for acute rejection
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The time to the first proven acute rejection
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The time to the treatment failure
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The total number of biopsy proven, acute rejection episodes, per patient
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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