Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05469906

Evaluation at 5 and 10 Years of Renal Transplant Patients

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Transplant; Complication, Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • Opposition to the use his medical data
  • patient deceased or with graft lost before M48

Treatment and study plan

Primary outcomes

  1. eGFR

    Time frame: 10 years

    estimated GFR (CKDEPI)

Secondary outcomes

  1. patient survival

    Time frame: 5 and 10 years

    patient survival at last follow-up

  2. graft survival

    Time frame: 5 and 10 years

    graft survival at last follow-up

  3. rejection rate

    Time frame: 5 and 10 years

    biopsy proven rejection

  4. infection rate

    Time frame: 5 and 10 years

    all infection episodes

  5. hospitalization

    Time frame: 5 and 10 years

    number of hospitalization, hospital stay

Study contacts

Contact information is provided by the study sponsor or research team.

Christelle RATAJCZAK

CONTACT

[email protected]

02.98.34.70.61

Yannick Le Meur, MD, PhD

CONTACT

[email protected]

02.98.34.70.74

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

Evaluation at 5 and 10 Years of Renal Transplant Patients Who Received a Graft Preserved in a Solution HEMO2life®

Acronym: OXYOP 5 and 10

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jul 22, 2022
Registry last updated
Jul 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.