Transplant; Complication, FailureOXYOP4NCT05050513
Evaluation of HEMO2Life® for Kidney Graft Preservation (OXYOP): 4 Years Follow-up
An observational study of Transplant; Complication, Failure, run by University Hospital, Brest at 1 site in France.
Trial summary
4 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
- 1 May 2021to Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Who cannot join
- patients refusing to participate
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Brest
Brest, 29609
Christelle Ratajczak, 0298347061, christelle.ratajaczak@chu-brest.fr
About this study
Official title: Evaluation of a Marine OXYgen Carrier (HEMO2Life®) for hypOthermic Kidney Graft Preservation Before Transplantation (OXYOP): 4 Years Follow-up
4 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). 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.
- 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 | kident 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: 4 years
Secondary outcomes (5)
patient survival
patient survival at last follow-up
Measured: 4 years
graft survival
graft survival at last follow-up
Measured: 4 years
rejection rate
biopsy proven rejection
Measured: 4 years
infection rate
all infection episodes
Measured: 4 years
hospitalization
number of hospitalization, hospital stay
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start1 May 2021
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (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
- NCT05050513
- Sponsor's protocol ID
- 229BRC21.0097
- Acronym
- OXYOP4
- Status last verified
- Jul 2021
- First submitted
- 6 Jul 2021
- Last updated
- 20 Sep 2021
- 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 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Marine OXYgen Carrier (HEMO2Life®) for hypOthermic Kidney Graft Preservation Before Transplantation (OXYOP): 4 Years Follow-up
- ClinicalTrials.gov ID
- NCT05050513
- Acronym / sponsor ID
- OXYOP4 / 229BRC21.0097
- Conditions
- Transplant; Complication, Failure
- Keywords
- renal transplantation, organ preservation, oxygen carrier
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 20 Sep 2021 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interventional group | – | –kidney graft preserved with M101 |
| control group | – | –kident 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 (1 listed)
- informed patients participating to the oxyop study
Key exclusion criteria (1 listed)
- patients refusing to participate
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: 4 years
estimated GFR (CKDEPI)
5 secondary outcomes
patient survival
Time frame: 4 years
graft survival
Time frame: 4 years
rejection rate
Time frame: 4 years
infection rate
Time frame: 4 years
hospitalization
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication.
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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. This study is not recruiting at the moment.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 Sep 2021. 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?
Results are not available in the source record.
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: 4 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 20 Sep 2021.