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Main
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Note: This record shows only 22 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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19 February 2015 |
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Main ID: |
NCT00384137 |
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Date of registration:
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04/10/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Kidney Recipients
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Scientific title:
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A Multicenter, Open, Single Sequence Crossover Study to Assess the Safety and Efficacy of a Tacrolimus Modified Release, FK506E (MR4), Based Immunosuppressive Regimen in Stable Kidney Transplant Patients Converted From a Prograf® Based Immunosuppressive Regimen |
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Date of first enrolment:
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October 2006 |
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Target sample size:
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128 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00384137 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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France
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Germany
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Netherlands
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Poland
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Spain
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United Kingdom
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Contacts
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Name:
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Use Central Contact |
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Address:
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Telephone:
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Email:
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Affiliation:
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Astellas Pharma GmbH |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Kidney transplant at least 12 months prior to enrollment.
- Prograf® dose remained unchanged for a minimum of 12 weeks prior to enrollment and
tacrolimus whole blood trough level measurements were in the range of 5-15 ng/mL.
Exclusion Criteria:
- Any unstable medical condition that could interfere with the study objectives in the
opinion of the investigator.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Transplantation
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Intervention(s)
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Drug: Tacrolimus
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Primary Outcome(s)
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Creatinine clearance
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Blood pressure, HbA1c, acute rejection
[Time Frame: 12 weeks]
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Secondary ID(s)
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PMR-EC-1205
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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