Evaluation of HEMO2Life® for Kidney Graft Preservation (OXYOP): 4 Years Follow-up (OXYOP4)

September 17, 2021 updated by: University Hospital, Brest

Evaluation of a Marine OXYgen Carrier (HEMO2Life®) for hypOthermic Kidney Graft Preservation Before Transplantation (OXYOP): 4 Years Follow-up

4 years follow-up of the oxyop study.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Oxyop (NCT02652520 PHRC) was a safety study evaluating the use of an oxygen carrier HEMO2life® as an additive in organ preservation solution in 60 transplanted kidneys. This was a national multicenter (6 centers) open-labeled safety study on HEMO2life® that included 58 recipients. The first patient was included on March 24th, 2016 and the study was completed on February 23th, 2018 (1 year of recruitment and 1 year of follow-up). We also analyzed some efficacy secondary end points using a paired analysis (local kidney receiving HEMO2life® versus contralateral kidney transplanted elsewhere in France). Oxyop4 aims to analyse 4 years results.

Study Type

Observational

Enrollment (Anticipated)

116

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

116 patients previously included in the oxyop study

Description

Inclusion Criteria:

  • informed patients participating to the oxyop study

Exclusion Criteria:

  • patients refusing to participate

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
interventional group
kidney graft preserved with M101
control group
kident graft preserved in standard condition (without M101)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
eGFR
Time Frame: 4 years
estimated GFR (CKDEPI)
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient survival
Time Frame: 4 years
patient survival at last follow-up
4 years
graft survival
Time Frame: 4 years
graft survival at last follow-up
4 years
rejection rate
Time Frame: 4 years
biopsy proven rejection
4 years
infection rate
Time Frame: 4 years
all infection episodes
4 years
hospitalization
Time Frame: 4 years
number of hospitalization, hospital stay
4 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, University hospital Brest France

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)

May 1, 2021

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

July 6, 2021

First Submitted That Met QC Criteria

September 17, 2021

First Posted (Actual)

September 20, 2021

Study Record Updates

Last Update Posted (Actual)

September 20, 2021

Last Update Submitted That Met QC Criteria

September 17, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 229BRC21.0097

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 five years following the final study report completion.

IPD Sharing 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

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

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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