NCT05050513

Brief Summary

4 years follow-up of the oxyop study.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

May 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 20, 2021

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

September 20, 2021

Status Verified

July 1, 2021

Enrollment Period

5 months

First QC Date

July 6, 2021

Last Update Submit

September 17, 2021

Conditions

Transplant; Complication, Failure

Keywords

renal transplantationorgan preservationoxygen carrier

Outcome Measures

Primary Outcomes (1)

  • eGFR

    estimated GFR (CKDEPI)

    4 years

Secondary Outcomes (5)

  • patient survival

    4 years

  • graft survival

    4 years

  • rejection rate

    4 years

  • infection rate

    4 years

  • hospitalization

    4 years

Study Arms (2)

interventional group

kidney graft preserved with M101

control group

kident 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

You may not qualify if:

  • patients refusing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Brest

Brest, 29609, France

RECRUITING

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 6, 2021

First Posted

September 20, 2021

Study Start

May 1, 2021

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

September 20, 2021

Record last verified: 2021-07

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)