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

• Conditions: Transplant; Complication, Failure

• Registration Number: NCT05050513
• Lead Sponsor: University Hospital, Brest

Brief Summary

4 years follow-up of the oxyop study.

Detailed 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.

Study Timeline

• Study Start: 2021-05-01
• Status Verified: 2021-07
• Study First Submitted: 2021-07-06
• Study First Submitted QC: 2021-09-17
• Last Update Submitted: 2021-09-17
• Study First Posted: 2021-09-20
• Last Update Posted: 2021-09-20
• Primary Completion: 2021-10
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• informed patients participating to the oxyop study

Exclusion Criteria

• patients refusing to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eGFR	4 years	estimated GFR (CKDEPI)

Secondary Outcome Measures

Name	Time	Method
rejection rate	4 years	biopsy proven rejection
infection rate	4 years	all infection episodes
hospitalization	4 years	number of hospitalization, hospital stay
patient survival	4 years	patient survival at last follow-up
graft survival	4 years	graft survival at last follow-up

Trial Locations

Locations (1)

CHU de Brest; 🇫🇷 Brest, France