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

Last updated: September 17, 2021
Sponsor: University Hospital, Brest
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05050513
229BRC21.0097
  • Ages > 18
  • All Genders

Study Summary

4 years follow-up of the oxyop study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • informed patients participating to the oxyop study

Exclusion

Exclusion Criteria:

  • patients refusing to participate

Study Design

Total Participants: 116
Study Start date:
May 01, 2021
Estimated Completion Date:
October 31, 2021

Study 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.

Connect with a study center

  • CHU de Brest

    Brest, 29609
    France

    Active - Recruiting

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