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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: |
NCT00481481 |
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Date of registration:
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30/05/2007 |
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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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Conversion Study From Cyclosporine to FK506MR Based Immunosuppression in Kidney Transplant Subjects
CONCERTO |
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Scientific title:
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A Multicenter, Single-arm, Open, Conversion Study From a Cyclosporine (CyA) Based Immunosuppressive Regimen to a Tacrolimus Modified Release, FK506E (MR4), Based Immunosuppressive Regimen in Kidney Transplant Subjects (CONCERTO: Converting Cyclosporine to FK506E (MR4) in Renal Transplantation) |
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Date of first enrolment:
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April 2007 |
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Target sample size:
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346 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00481481 |
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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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Austria
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Belgium
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Czech Republic
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Denmark
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Finland
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France
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Germany
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Hungary
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Italy
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Poland
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Spain
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Sweden
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Switzerland
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Contacts
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Name:
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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:
- Serum creatinine < 200 µmol/l (< 2.3 mg/dl) at enrollment.
- Female subject of childbearing potential must have a negative serum pregnancy test at
enrollment and must agree to maintain effective birth control during the study.
- Capable of understanding the purpose and risks of the study, has been fully informed
and has given written informed consent (signed Informed Consent has been obtained).
Exclusion Criteria:
- Previously received an organ transplant other than a kidney.
- Acute rejection episode within 12 weeks prior to enrollment, or an acute rejection
episode within the 24 weeks prior to enrollment that required anti-lymphocyte
antibody therapy
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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Change in creatinine clearance, calculated according to Cockcroft and Gault formula.
[Time Frame: Week 24]
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Secondary Outcome(s)
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Rating of subjects according to reason for conversion: Changes in mean lipid levels (total cholesterol)
[Time Frame: Week 24]
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Change in creatinine clearance, calculated according to Cockcroft and Gault formula, between Baseline (Day 1) and week 24 (End of Study) overall
[Time Frame: Week 24]
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Secondary ID(s)
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PMR-EC-1209
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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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