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

NCT ID: NCT05050513

Last Updated: 2021-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-01

Study Completion Date

2021-10-31

Brief Summary

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4 years follow-up of the oxyop study.

Detailed Description

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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.

Conditions

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Transplant; Complication, Failure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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interventional group

kidney graft preserved with M101

No interventions assigned to this group

control group

kident graft preserved in standard condition (without M101)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* informed patients participating to the oxyop study

Exclusion Criteria

* patients refusing to participate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yannick le Meur

Role: PRINCIPAL_INVESTIGATOR

University hospital Brest France

Locations

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CHU de Brest

Brest, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Yannick Le Meur, MD, PhD

Role: CONTACT

02.98.34.70.74

Christelle Ratajczak

Role: CONTACT

02.98.34.70.61

Facility Contacts

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Christelle Ratajczak

Role: primary

0298347061

Other Identifiers

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229BRC21.0097

Identifier Type: -

Identifier Source: org_study_id

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