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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RECRUITING
260 participants
OBSERVATIONAL
2024-08-23
2025-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Active Comparator: Control
Drug: Anti R-IL2 + Cyclosporine
* Anti R-IL2 induction (Simulect ®, 20 mg D0 and D4)
* Mycophenolate Mofetil (Cellcept ®) 3 grams per day beginning at D0
* Cyclosporine A (Neoral ®) started from 6 to 8 mg/kg adjusted to C2
* Corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6
No interventions assigned to this group
Experimental: CNI-free
Drug: Thymoglobulin + Everolimus
* Thymoglobulin ® induction started at 1.5mg/kg/j then adjusted to CD2 or total lymphocytes count, for 5 days
* Mycophenolate Mofetil (Cellcept ®) 3 grams per day beginning at D0
* Everolimus (Certican ®): 4 to 6 mg/day started at D5, adjusted to achieve a residual level between 6 et 10 ng/ml
* Corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6
No interventions assigned to this group
Experimental: Switch
Drug: Anti R-IL2 + Cyclosporine then Everolimus
* Anti R-IL2 induction (Simulect ®, 20 mg D0 and D4)
* Mycophenolate Mofetil (Cellcept ®) 3 g/d beginning at D0
* Cyclosporine A (Neoral ®) beginning at 6 to 8 mg/kg adjusted to C2, then switch to everolimus (Certican ®) between at W6, started at 3 mg/d, then adjusted to achieve a residual level between 6 et 10 ng/ml
* Corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patient having completed the EVEROLD M12 follow-up visit
* Patient agreeing to participate in the observational study
Exclusion Criteria
* Patient under legal protection
18 Years
ALL
No
Sponsors
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University Hospital, Brest
OTHER
Responsible Party
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Principal Investigators
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Yannick LE MEUR
Role: PRINCIPAL_INVESTIGATOR
CHU Brest
Locations
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Chu Amiens
Amiens, , France
CHU Bordeaux
Bordeaux, , France
Chu Brest
Brest, , France
CHU Lille
Lille, , France
CHU Limoges
Limoges, , France
CHU Nice Pasteur 2
Nice, , France
CHU Nice
Nice, , France
Hôpital Necker
Paris, , France
Chu Poitiers
Poitiers, , France
CHU Rennes
Rennes, , France
CHU Rouen
Rouen, , France
CHU Strasbourg
Strasbourg, , France
CHU Toulouse Rangueil
Toulouse, , France
CHU Tours
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Antoine SICARD, Pr
Role: primary
Other Identifiers
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29BRC23.0069 - Everold FUP
Identifier Type: -
Identifier Source: org_study_id
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