Transplant; Complication, FailureOXYOP 5 and 10NCT05469906
Evaluation at 5 and 10 Years of Renal Transplant Patients
An observational study of Transplant; Complication, Failure, run by University Hospital, Brest at 1 site in France.
Trial summary
5 and 10 years follow-up of the oxyop study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplant; Complication, Failure
- How many people
- 116 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2022to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 116 patients previously included in the oxyop study
Who may be able to join
- informed patients participating to the oxyop study
- Patient having completed the OXYOP M12 follow-up visit
- Patient agreeing to participate in the observational study
Who cannot join
- Opposition to the use his medical data
- patient deceased or with graft lost before M48
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHRU Brest
Brest, 29200
Yannick LE MEUR, yannick.lemeur@chu-brest.fr
Christelle RATAJCZAK, christelle.ratajczak@chu-brest.fr
About this study
Official title: Evaluation at 5 and 10 Years of Renal Transplant Patients Who Received a Graft Preserved in a Solution HEMO2life®
5 and 10 years follow-up of the oxyop study.
Read the 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
- Keywords
- renal transplantation, organ preservation, oxygen carrier
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| interventional group | kidney graft preserved with M101 | |
| control group | kidney graft preserved in standard condition (without M101) |
What is being measured
The primary outcome is the main question the study is designed to answer.
eGFR
estimated GFR (CKDEPI)
Measured: 10 years
Secondary outcomes (5)
patient survival
patient survival at last follow-up
Measured: 5 and 10 years
graft survival
graft survival at last follow-up
Measured: 5 and 10 years
rejection rate
biopsy proven rejection
Measured: 5 and 10 years
infection rate
all infection episodes
Measured: 5 and 10 years
hospitalization
number of hospitalization, hospital stay
Measured: 5 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study startJul 2022 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant; Complication, FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yannick Le Meur, Principal investigator, University hospital Brest France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05469906
- Sponsor's protocol ID
- OXYOP 5 and 10 (29BRC22.0144)
- Acronym
- OXYOP 5 and 10
- Status last verified
- Jul 2022
- First submitted
- 4 Jul 2022
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation at 5 and 10 Years of Renal Transplant Patients Who Received a Graft Preserved in a Solution HEMO2life®
- ClinicalTrials.gov ID
- NCT05469906
- Acronym / sponsor ID
- OXYOP 5 and 10 / OXYOP 5 and 10 (29BRC22.0144)
- Conditions
- Transplant; Complication, Failure
- Keywords
- renal transplantation, organ preservation, oxygen carrier
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interventional group | – | –kidney graft preserved with M101 |
| control group | – | –kidney graft preserved in standard condition (without M101) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 116 patients previously included in the oxyop study
Key inclusion criteria (3 listed)
- informed patients participating to the oxyop study
- Patient having completed the OXYOP M12 follow-up visit
- Patient agreeing to participate in the observational study
Key exclusion criteria (2 listed)
- Opposition to the use his medical data
- patient deceased or with graft lost before M48
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
eGFR
Time frame: 10 years
estimated GFR (CKDEPI)
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication.
Related trials for Transplant; Complication, Failure
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ECP-DL Cell Infusion for Induction in Living Donor Kidney (LDK) Transplants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yannick Le Meur principal investigator
University hospital Brest France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplant; Complication, Failure, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yannick Le Meur, MD, PhD (02.98.34.70.74, yannick.lemeur@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eGFR (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.