NCT05469906

Evaluation at 5 and 10 Years of Renal Transplant Patients

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 116 (estimated)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

5 and 10 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). 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.

Conditions

• Transplant; Complication, Failure

Timeline

• Start date: 2022-07-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2022-07-22
• Last updated: 2022-07-22

Locations

1 site across 1 country: France