EVEROLD LONG TERM FOLLOW-UP
EVEROLD FUP
Long-term Evaluation of the Value of Using an MTor Inhibitor (everolimus) for the Minimisation of Anticalceurins in Old-for-old Kidney Transplantation
1 other identifier
observational
260
1 country
14
Brief Summary
Long Term Follow up of EVEROLD study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2024
Shorter than P25 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2024
CompletedFirst Posted
Study publicly available on registry
July 16, 2024
CompletedStudy Start
First participant enrolled
August 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedFebruary 6, 2025
September 1, 2024
11 months
July 10, 2024
February 4, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Patient survival
Patient survival at last follow-up
up to 12 years
Graft survival
Graft survival at last follow-up
up to 12 years
Secondary Outcomes (6)
Rejection rate
up to 12 years
Infection rate
up to 12 years
Major cardiovascular events
up to 12 years
Cancer rate
up to 12 years
Hospitalization
up to 12 years
- +1 more secondary outcomes
Study Arms (3)
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
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
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
Eligibility Criteria
260 patients previously included in the EVEROLD study
You may qualify if:
- Informed patients participating to the EVEROLD study
- Patient having completed the EVEROLD M12 follow-up visit
- Patient agreeing to participate in the observational study
You may not qualify if:
- Opposition to the use his medical data
- Patient under legal protection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
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
Study Officials
- PRINCIPAL INVESTIGATOR
Yannick LE MEUR
CHU Brest
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2024
First Posted
July 16, 2024
Study Start
August 23, 2024
Primary Completion
August 1, 2025
Study Completion
August 1, 2025
Last Updated
February 6, 2025
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be available beginning three years and ending fifteen years following the final study report completion
- Access Criteria
- Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement
All collected data that underlie results in a publication