Study Evaluating the Benefit of Two Immunosuppressive Strategies on Renal Function
NCT ID: NCT02334488
Last Updated: 2021-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
329 participants
INTERVENTIONAL
2014-12-11
2020-07-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Everolimus-Tacrolimus
* Tacrolimus (Prograf®) started at 0,1 mg/kg/day since Day0, then adapted to C0 concentration (4-7 ng/ml),
* Everolimus (Certican®) started within 24h after reperfusion, to be adapted to C0 concentration (3-8 ng/ml).
Everolimus
Active Comparator
Tacrolimus
Active Comparator
Everolimus-Mycophenolate sodium
* Everolimus (Certican®) started within 24h after reperfusion, to be adapted to C0 concentration (3-8 ng/ml),
* Tacrolimus (Prograg®) started at 0,1 mg/kg/day from J0 then to be adapted to C0 concentration (4-7 ng/ml), then replacement by mycophenolate sodium (Myfortic®) at M3 (3 months visit) started at 1440 mg/day.
Everolimus
Active Comparator
Mycophenolate sodium
Experimental Arm
Interventions
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Everolimus
Active Comparator
Tacrolimus
Active Comparator
Mycophenolate sodium
Experimental Arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patient who has been treated with an immunosuppressive drug or study drug during the four weeks before administration of the first dose of Everolimus
18 Years
ALL
No
Sponsors
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Poitiers University Hospital
OTHER
Responsible Party
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Principal Investigators
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Antoine THIERRY, MD
Role: PRINCIPAL_INVESTIGATOR
Poitiers University Hospital
Locations
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Amiens University Hospital
Amiens, , France
Angers University Hospital
Angers, , France
Brest University Hospital
Brest, , France
Caen University Hospital
Caen, , France
Clermont Ferrand University Hospital
Clermont-Ferrand, , France
Limoges University Hospital
Limoges, , France
Georges Pompidou European Hospital
Paris, , France
Necker Hospital
Paris, , France
Poitiers University Hospital
Poitiers, , France
Reims University Hospital
Reims, , France
Rennes University Hospital
Rennes, , France
Rouen University Hospital
Rouen, , France
Strasbourg University Hospital
Strasbourg, , France
Tours University Hospital
Tours, , France
Countries
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Other Identifiers
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PROMéTé
Identifier Type: -
Identifier Source: org_study_id
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