NCT05469906

Brief Summary

5 and 10 years follow-up of the oxyop study.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Jul 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress71%
Jul 2022Dec 2027

Study Start

First participant enrolled

July 1, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 4, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 22, 2022

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

5.4 years

First QC Date

July 4, 2022

Last Update Submit

July 21, 2022

Conditions

Transplant; Complication, Failure

Keywords

renal transplantationorgan preservationoxygen carrier

Outcome Measures

Primary Outcomes (1)

  • eGFR

    estimated GFR (CKDEPI)

    10 years

Secondary Outcomes (5)

  • patient survival

    5 and 10 years

  • graft survival

    5 and 10 years

  • rejection rate

    5 and 10 years

  • infection rate

    5 and 10 years

  • hospitalization

    5 and 10 years

Study Arms (2)

interventional group

kidney graft preserved with M101

control group

kidney graft preserved in standard condition (without M101)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

116 patients previously included in the oxyop study

You may qualify if:

  • informed patients participating to the oxyop study
  • Patient having completed the OXYOP 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 deceased or with graft lost before M48

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Brest

Brest, 29200, France

Location

Study Officials

  • Yannick Le Meur

    University hospital Brest France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yannick Le Meur, MD, PhD

CONTACT

02.98.34.70.74yannick.lemeur@chu-brest.fr

Christelle RATAJCZAK

CONTACT

02.98.34.70.61christelle.ratajaczak@chu-brest.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2022

First Posted

July 22, 2022

Study Start

July 1, 2022

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

July 22, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication.

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available beginning three years and ending five years following the final study report completion.
Access Criteria
Data access request will be reviewed by the internal committee of Brest University Hospital. Requestor will be required to sign and complete a data access agreement

Locations

FR(1)