Evaluation at 5 and 10 Years of Renal Transplant Patients
- Conditions
- Transplant; Complication, Failure
- Registration Number
- NCT05469906
- Lead Sponsor
- University Hospital, Brest
- Brief 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 116
- informed patients participating to the oxyop study
- Patient having completed the OXYOP M12 follow-up visit
- Patient agreeing to participate in the observational study
- Opposition to the use his medical data
- patient deceased or with graft lost before M48
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eGFR 10 years estimated GFR (CKDEPI)
- Secondary Outcome Measures
Name Time Method infection rate 5 and 10 years all infection episodes
rejection rate 5 and 10 years biopsy proven rejection
graft survival 5 and 10 years graft survival at last follow-up
hospitalization 5 and 10 years number of hospitalization, hospital stay
patient survival 5 and 10 years patient survival at last follow-up
Trial Locations
- Locations (1)
CHRU Brest
🇫🇷Brest, France