Transplant; Complication, FailureEVEROLD FUPNCT06504225
EVEROLD LONG TERM FOLLOW-UP
An observational study of Transplant; Complication, Failure, run by University Hospital, Brest at 14 sites in France.
Trial summary
Long Term Follow up of EVEROLD study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplant; Complication, Failure
- Type of treatment
- Injection or infusion
- How many people
- 260 participants
- Where
- 14 sitesFrance
- Study dates
- 23 Aug 2024to 1 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 260 patients previously included in the EVEROLD study
Who may be able to join
- Informed patients participating to the EVEROLD study
- Patient having completed the EVEROLD M12 follow-up visit
- Patient agreeing to participate in the observational study
Who cannot join
- Opposition to the use his medical data
- Patient under legal protection
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites, 14 recruiting
- Recruiting
Chu Amiens
Amiens
Coralie POULAIN, Dr, 03 22 45 58 60, coralie.poulain@chu-amiens.fr
- Recruiting
CHU Bordeaux
Bordeaux
Lionel COUZI, Pr, lionel.couzi@chu-bordeaux.fr
- Recruiting
Chu Brest
Brest
Yannick LE MEUR, Pr, yannick.lemeur@chu-brest.fr
- Recruiting
CHU Lille
Lille
Marc HAZZAN, Pr, 03 20 44 59 62, marc.hazzan@univ-lille.fr
- Recruiting
CHU Limoges
Limoges
Jean-Philippe REROLLE, Dr, 05 55 05 55 55, jean-philippe.rerolle@chu-limoges.fr
- Recruiting
CHU Nice Pasteur 2
Nice
Antoine SICARD, Pr
- Recruiting
CHU Nice
Nice
Antoine SICARD, Pr, 03 80 29 30 31, sicard.a@chu.nice.fr
- Recruiting
Hôpital Necker
Paris
Dany ANGLICHEAU, Pr, 01 44 49 40 00, dany.anglicheau@aphp.fr
- Recruiting
Chu Poitiers
Poitiers
Antoine THIERRY, Pr, 05 49 44 44 44, antoine.thierry@chu-poitiers.fr
- Recruiting
CHU Rennes
Rennes
Elsa VABRET, Dr, 02 99 28 43 21 ext. +33, elsa.vabret@chu-rennes.fr
- Recruiting
CHU Rouen
Rouen
Dominique BERTRAND, Dr, 02 32 88 89 90, dominique.bertrand@chu-rouen.fr
- Recruiting
CHU Strasbourg
Strasbourg
Sophie CAILLARD-OHLMANN, Pr, 03 88 11 67 68, sophie.ohlmann@chru-strasbourg.fr
- Recruiting
CHU Toulouse Rangueil
Toulouse
Nassim KAMAR, Pr, 05 61 77 22 33, kamar.n@chu-toulouse.fr
- Recruiting
CHU Tours
Tours
Matthias BUCHLER, Pr, 02 47 47 47 47, buchler@med.univ-tours.fr
About this study
Official title: Long-term Evaluation of the Value of Using an MTor Inhibitor (everolimus) for the Minimisation of Anticalceurins in Old-for-old Kidney Transplantation
Long Term Follow up of EVEROLD study
- Conditions
- Transplant; Complication, Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient survival
Patient survival at last follow-up
Measured: up to 12 years
Graft survival
Graft survival at last follow-up
Measured: up to 12 years
Secondary outcomes (6)
Rejection rate
Biopsy proven rejection
Measured: up to 12 years
Infection rate
All infections requiring hospitalization
Measured: up to 12 years
Major cardiovascular events
Measured: up to 12 years
Cancer rate
Skin cancer, solid organ tumor and hematological cancer
Measured: up to 12 years
Hospitalization
Number of hospitalization, hospital stay, reason for hospitalization
Measured: up to 12 years
eGFR
estimated GFR (MDRD and CKD-EPI)
Measured: up to 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start23 Aug 2024
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant; Complication, FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yannick LE MEUR, Principal investigator, CHU Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504225
- Sponsor's protocol ID
- 29BRC23.0069 - Everold FUP
- Acronym
- EVEROLD FUP
- Status last verified
- Sep 2024
- First submitted
- 10 Jul 2024
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Evaluation of the Value of Using an MTor Inhibitor (everolimus) for the Minimisation of Anticalceurins in Old-for-old Kidney Transplantation
- ClinicalTrials.gov ID
- NCT06504225
- Acronym / sponsor ID
- EVEROLD FUP / 29BRC23.0069 - Everold FUP
- Conditions
- Transplant; Complication, Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 23 Aug 2024 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Long Term Follow up of EVEROLD study
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 260 patients previously included in the EVEROLD study
Key inclusion criteria (3 listed)
- Informed patients participating to the EVEROLD study
- Patient having completed the EVEROLD M12 follow-up visit
- Patient agreeing to participate in the observational study
Key exclusion criteria (2 listed)
- Opposition to the use his medical data
- Patient under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient survival
Time frame: up to 12 years
Patient survival at last follow-up
Graft survival
Time frame: up to 12 years
Graft survival at last follow-up
6 secondary outcomes
Rejection rate
Time frame: up to 12 years
Infection rate
Time frame: up to 12 years
Major cardiovascular events
Time frame: up to 12 years
Cancer rate
Time frame: up to 12 years
Hospitalization
Time frame: up to 12 years
eGFR
Time frame: up to 12 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Related trials for Transplant; Complication, Failure
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Study of ChoironeX GalKO Porcine Thymokidney Xenotransplantation in End-Stage Renal Disease
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Central Blood Pressure and Pulse Wave Velocity in Kidney Transplant Recipients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yannick LE MEUR principal investigator
CHU Brest
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplant; Complication, Failure, run by University Hospital, Brest at 14 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yannick Le Meur (+330298347014, yannick.lemeur@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient survival (time frame: up to 12 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.