Evaluation at 5 and 10 Years of Renal Transplant Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Transplant; Complication, Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation at 5 and 10 Years of Renal Transplant Patients Who Received a Graft Preserved in a Solution HEMO2life®
Overview
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.
Primary outcome measures
- eGFR [Time frame: 10 years]
Secondary outcome measures (5)
- patient survival [Time frame: 5 and 10 years]
- graft survival [Time frame: 5 and 10 years]
- rejection rate [Time frame: 5 and 10 years]
- infection rate [Time frame: 5 and 10 years]
- hospitalization [Time frame: 5 and 10 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
France · 1 center
- CHRU Brest — Brest
Identifiers
NCT: NCT05469906 · OXYOP 5 and 10 (29BRC22.0144)