EVEROLD LONG TERM FOLLOW-UP (EVEROLD FUP)

Regional University Hospital Center (CHRU)

Status: Enrolling

Conditions: Transplant; Complication, Failure

Study type: Observational

Funder types: Other

Identifiers

NCT06504225

29BRC23.0069 - Everold FUP

Details and patient eligibility

About

Long Term Follow up of EVEROLD study

Enrollment: 260 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed patients participating to the EVEROLD study
• Patient having completed the EVEROLD M12 follow-up visit
• Patient agreeing to participate in the observational study

Exclusion criteria

• Opposition to the use his medical data
• Patient under legal protection

Trial design

260 participants in 3 patient groups

Active Comparator: Control

Description:

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

Experimental: CNI-free

Description:

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

Experimental: Switch

Description:

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