Evaluation at 5 and 10 Years of Renal Transplant Patients

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

NOT_YET_RECRUITING

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-31

Study Completion Date

2027-12-31

Brief Summary

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

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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). Some efficacy secondary end points using a paired analysis was also analyzed (local kidney receiving HEMO2life® versus contralateral kidney transplanted elsewhere in France). Oxyop 5 and 10 years aims to analyse 5 and 10 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

kidney 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
* Patient having completed the OXYOP M12 follow-up visit
* Patient agreeing to participate in the observational study