Evaluation of HEMO2Life® for Kidney Graft Preservation (OXYOP): 4 Years Follow-up (OXYOP4)

Regional University Hospital Center (CHRU)

Status: Unknown

Conditions: Transplant; Complication, Failure

Study type: Observational

Funder types: Other

Identifiers

NCT05050513

229BRC21.0097

Details and patient eligibility

About

4 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). 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.

Enrollment: 116 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• informed patients participating to the oxyop study

Exclusion criteria

• patients refusing to participate

Trial design

116 participants in 2 patient groups

interventional group

Description:

kidney graft preserved with M101

control group

Description:

kident graft preserved in standard condition (without M101)