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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: |
NCT00296361 |
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Date of registration:
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23/02/2006 |
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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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To Compare the Efficacy and Safety of a Therapy of Tacrolimus With Sirolimus or MMF in Kidney Transplantation.
RESTORE |
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Scientific title:
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A Multicentre, Randomised, Open Clinical Study to Compare the Efficacy and Safety of a Combination Therapy of Tacrolimus With Sirolimus Versus Tacrolimus With Mycophenolate Mofetil in Kidney Transplantation. |
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Date of first enrolment:
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October 2004 |
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Target sample size:
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634 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00296361 |
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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: Prevention
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Austria
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Belgium
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Czech Republic
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France
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Germany
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Hungary
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Italy
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Netherlands
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Poland
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Romania
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Spain
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Sweden
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United Kingdom
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Contacts
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Name:
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Medical Physician |
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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 Europe B.V. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients between 18 and 60 years of age and having end stage kidney disease who will
undergo primary renal transplantation or retransplantation are eligible for the
study. Patients receiving a kidney transplant, from a cadaveric or living donor (not
HLA identical) with compatible AB0 blood type can be included.
Exclusion Criteria:
- Patient has a high immunological risk
- Cold ischemia time greater than 30 hours
- Patient has significant liver disease
- Patient has severe hypercholesterolaemia
- Patient is allergic or intolerant to study medication
- Patient requires ongoing dosing with corticosteroids.
- Patient or donor is known to be HIV positive
- Patient with malignancy or history of malignancy
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Kidney Transplantation
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Intervention(s)
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Drug: Tacrolimus
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Primary Outcome(s)
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Renal function as assessed by calculated creatinine clearance at month 6.
[Time Frame: 6 months]
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Secondary Outcome(s)
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Acute rejection: Incidence of and time to first acute rejection
[Time Frame: 6 months]
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Secondary ID(s)
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FG-506-02-40
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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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