Evaluation at 5 and 10 Years of Renal Transplant Patients (OXYOP 5 and 10)

Regional University Hospital Center (CHRU)

Status: Not yet enrolling

Conditions: Transplant; Complication, Failure

Study type: Observational

Funder types: Other

Identifiers

NCT05469906

OXYOP 5 and 10 (29BRC22.0144)

Details and patient eligibility

About

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

Full 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). 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.

Enrollment: 116 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

116 participants in 2 patient groups

interventional group

Description:

kidney graft preserved with M101

control group

Description:

kidney graft preserved in standard condition (without M101)