EVEROLD LONG TERM FOLLOW-UP (EVEROLD FUP)

February 4, 2025 updated by: University Hospital, Brest

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

260 patients previously included in the EVEROLD study

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient survival
Time Frame: up to 12 years
Patient survival at last follow-up
up to 12 years
Graft survival
Time Frame: up to 12 years
Graft survival at last follow-up
up to 12 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rejection rate
Time Frame: up to 12 years
Biopsy proven rejection
up to 12 years
Infection rate
Time Frame: up to 12 years
All infections requiring hospitalization
up to 12 years
Major cardiovascular events
Time Frame: up to 12 years
up to 12 years
Cancer rate
Time Frame: up to 12 years
Skin cancer, solid organ tumor and hematological cancer
up to 12 years
Hospitalization
Time Frame: up to 12 years
Number of hospitalization, hospital stay, reason for hospitalization
up to 12 years
eGFR
Time Frame: up to 12 years
estimated GFR (MDRD and CKD-EPI)
up to 12 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

  • Principal Investigator: Yannick LE MEUR, CHU Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

July 10, 2024

First Submitted That Met QC Criteria

July 10, 2024

First Posted (Actual)

July 16, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 4, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 29BRC23.0069 - Everold FUP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available beginning three years and ending fifteen years following the final study report completion

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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