End Stage Renal DiseasesOXYOP 2NCT04181710
Evaluation of a Marine OXYgen Carrier for Organ Preservation
A study testing Kidney transplant in people with End Stage Renal Diseases, run by University Hospital, Brest at 32 sites in France.
Trial summary
Preventing ischemia/reperfusion injuries (IRIs) is a major issue in kidney transplantation, particularly for transplant recipients receiving a kidney from extended criteria donors (ECD). The main consequence of IRIs is delayed graft function (DGF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Diseases
- What is being tested?
- Kidney transplant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 490 participants
- Where
- 32 sitesFrance
- Study dates
- 4 Jul 2020to 11 Sep 2023
- Phase
- Interventional
- 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
Who may be able to join
- For Kidney graft:
- Any pair of kidneys retrieved in an adult donor in one of first line participating centers.
- Any pair of kidneys from a deceased donor after brain or cardiac death
- For Patient:
- Male or female renal allograft recipients at least 18 years old
- Patient who signed an inform consent form
- Patient receiving one graft from an included pair of kidneys
Who cannot join
- For kidney :
- Graft from a living donor
- Graft dedicated to a multi-organ transplantation or dual kidney transplantation,
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
France32 sites
Amiens
Amiens
Angers
Angers
Besançon
Besançon
Bordeaux
Bordeaux
CHRU de Brest
Brest
Caen
Caen
Clermont-Ferrand
Clermont-Ferrand
Dijon
Dijon
Grenoble
Grenoble
Lille
Lille
Limoges
Limoges
Lyon
Lyon
Marseille
Marseille
Montpellier
Montpellier
Nancy
Nancy
Nantes
Nantes
Nice
Nice
APHP Bicêtre
Paris
APHP Henri Mondor
Paris
APHP Necker
Paris
APHP Saint-Louis
Paris
Association Hopital Foch
Paris
Paris La Salpétrière
Paris
Poitiers
Poitiers
Reims
Reims
Rennes
Rennes
Rouen
Rouen
La Réunion
Saint-Denis
Saint-Etienne
Saint-Etienne
Strasbourg
Strasbourg
Toulouse
Toulouse
Tours
Tours
About this study
Official title: Evaluation of a Marine OXYgen Carrier for Organ Preservation : a Multicenter Randomized Study Evaluating the Efficacy of HEMO2life® Versus Standard of Care in Renal Transplantation
Preventing ischemia/reperfusion injuries (IRIs) is a major issue in kidney transplantation, particularly for transplant recipients receiving a kidney from extended criteria donors (ECD). The main consequence of IRIs is delayed graft function (DGF).
The medical device HEMO2life®, an oxygen carrier developed by the Hemarina French Company, is a natural extracellular hemoglobin (Hb) isolated from the marine lugworm Arenicola marina. This biopolymer of high molecular weight (~3,600 kDa) has a large oxygen binding capacity, carrying up to 156 oxygen molecules when saturated (4 for human Hb). It releases oxygen according to a simple gradient and exhibits an intrinsic superoxide dismutase-like activity preventing both the occurrence of potentially harmful heme-protein-associated free radical species and the release of Hb degradation products.
Read more
Recently a safety study in 60 renal grafts using HEMO2life® as additive to organ preservation solution (Oxyop study, NCT02652520) was completed, that confirmed that the use of HEMO2life® is safe for patients and grafts.
In the Oxyop study, even if the protocol was not designed to show a benefit of the use of HEMO2life®, significantly less delayed graft function (DGF) and a shorter renal function recovery was observed.
The present research focuses on the efficacy of HEMO2life®, which is an oxygen carrier added in preservation solution in kidney transplantation.
- Conditions
- End Stage Renal Diseases
- Being tested
- Kidney transplant
- Keywords
- Kidney transplantation, Organ preservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kidney transplantProcedure or surgery
Organ preserved in preservation solution
| Study group | Role | What they receive |
|---|---|---|
| HEMO2life | Experimental | HEMO2life® will be used for ex vivo graft preservation at the dose of 1g per liter of preservation solution. Receives: Procedure: Kidney transplant |
| Control | Other | Organ preserved in preservation solution routinely used according to the local practice Receives: Procedure: Kidney transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of HEMO2life® as an additive to standard organ preservation solution to prevent delayed graft function following renal transplantation.
Delayed graft function defined as the requirement for dialysis during the first week after transplantation will be compared as per the confirmatory testing strategy
Measured: From day 0 to day 7
Secondary outcomes (6)
Assess and compare graft and patient survival in the two groups.
Graft and patient survival at one year
Measured: From month 0 to month 12
Efficacy of HEMO2life® on renal parameters compared with standard of care
Evaluation using DGF assessed with alternative definitions: more than one dialysis session, need for dialysis except for hyperkaliemia or overhydration reason, time to reach a creatinine value of 250 µmol/l, DGF duration and using Renal function (creatinine value and eGFR)
Measured: From month 0 to month 12
Efficacy in specific populations depending on type of donors and the type of preservation solution.
Rate of primary non function
Measured: From month 0 to month 12
Evaluate the impact of HEMO2Life® on the degree and progression of interstitial fibrosis on the pre-implantation and 3 month biopsies
Rate of biopsy-proven acute rejection at one year
Measured: biopsies pre-implantation and month 3
Evaluate the impact of HEMO2life® on quality of life following renal transplant at Month-1, 3 and 12.
Quality of life assess using the generic self-administered questionnaire EuroQol-5 Dimensions (EQ-5D) and a specific questionnaire for renal transplant recipients in the French language: the ReTransQol (RTQ) [0-100]. For RTQ, higher score mean a better outcome.
Measured: From Day 0 to month 12
Safety profile of HEMO2life® post transplant
Safety profile of HEMO2life® post transplant based on 3 analysis : graft safety, recipient safety, graft function
Measured: From organ preservation to month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start4 Jul 2020
- Primary completion12 Jul 2022
- Study completion11 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 490 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yannick LE MEUR, Principal investigator, Principal Investigator and Nephrology coordinatorBenoit BARROU, Principal investigator, Urology coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181710
- Sponsor's protocol ID
- OXYOP 2 (29BRC19.0048)
- Acronym
- OXYOP 2
- Status last verified
- Nov 2023
- First submitted
- 27 Nov 2019
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Publications
Tingle SJ, Thompson ER, Figueiredo RS, Moir JA, Goodfellow M, Talbot D, Wilson CH. Normothermic and hypothermic machine perfusion preservation versus static cold storage for deceased donor kidney transplantation. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD011671. doi: 10.1002/14651858.CD011671.pub3.
PubMed 38979743Le Meur Y, Nowak E, Barrou B, Thierry A, Badet L, Buchler M, Rerolle JP, Golbin L, Duveau A, Dantal J, Merville P, Kamar N, Demini L, Zal F. Evaluation of the efficacy of HEMO2life(R), a marine OXYgen carrier for Organ Preservation (OxyOp2) in renal transplantation: study protocol for a multicenter randomized trial. Trials. 2023 May 1;24(1):302. doi: 10.1186/s13063-023-07302-3.
PubMed 37127632
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Marine OXYgen Carrier for Organ Preservation : a Multicenter Randomized Study Evaluating the Efficacy of HEMO2life® Versus Standard of Care in Renal Transplantation
- ClinicalTrials.gov ID
- NCT04181710
- Acronym / sponsor ID
- OXYOP 2 / OXYOP 2 (29BRC19.0048)
- Conditions
- End Stage Renal Diseases
- Keywords
- Kidney transplantation, Organ preservation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 4 Jul 2020 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 11 Sep 2023 (actual)
- First posted
- 29 Nov 2019 (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.
Preventing ischemia/reperfusion injuries (IRIs) is a major issue in kidney transplantation, particularly for transplant recipients receiving a kidney from extended criteria donors (ECD). The main consequence of IRIs is delayed graft function (DGF).
The medical device HEMO2life®, an oxygen carrier developed by the Hemarina French Company, is a natural extracellular hemoglobin (Hb) isolated from the marine lugworm Arenicola marina. This biopolymer of high molecular weight (~3,600 kDa) has a large oxygen binding capacity, carrying up to 156 oxygen molecules when saturated (4 for human Hb). It releases oxygen according to a simple gradient and exhibits an intrinsic superoxide dismutase-like activity preventing both the occurrence of potentially harmful heme-protein-associated free radical species and the release of Hb degradation products.
Recently a safety study in 60 renal grafts using HEMO2life® as additive to organ preservation solution (Oxyop study, NCT02652520) was completed, that confirmed that the use of HEMO2life® is safe for patients and grafts.
In the Oxyop study, even if the protocol was not designed to show a benefit of the use of HEMO2life®, significantly less delayed graft function (DGF) and a shorter renal function recovery was observed.
The present research focuses on the efficacy of HEMO2life®, which is an oxygen carrier added in preservation solution in kidney transplantation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEMO2life | Experimental | Procedure: Kidney transplantHEMO2life® will be used for ex vivo graft preservation at the dose of 1g per liter of preservation solution. |
| Control | Other | Procedure: Kidney transplantOrgan preserved in preservation solution routinely used according to the local practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- For Kidney graft:
- Any pair of kidneys retrieved in an adult donor in one of first line participating centers.
- Any pair of kidneys from a deceased donor after brain or cardiac death
- For Patient:
- Male or female renal allograft recipients at least 18 years old
Key exclusion criteria (3 listed)
- For kidney :
- Graft from a living donor
- Graft dedicated to a multi-organ transplantation or dual kidney transplantation,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kidney transplantOrgan preserved in preservation solution | Procedure or surgery | Control, HEMO2life |
Primary outcome
Efficacy of HEMO2life® as an additive to standard organ preservation solution to prevent delayed graft function following renal transplantation.
Time frame: From day 0 to day 7
Delayed graft function defined as the requirement for dialysis during the first week after transplantation will be compared as per the confirmatory testing strategy
6 secondary outcomes
Assess and compare graft and patient survival in the two groups.
Time frame: From month 0 to month 12
Efficacy of HEMO2life® on renal parameters compared with standard of care
Time frame: From month 0 to month 12
Efficacy in specific populations depending on type of donors and the type of preservation solution.
Time frame: From month 0 to month 12
Evaluate the impact of HEMO2Life® on the degree and progression of interstitial fibrosis on the pre-implantation and 3 month biopsies
Time frame: biopsies pre-implantation and month 3
Evaluate the impact of HEMO2life® on quality of life following renal transplant at Month-1, 3 and 12.
Time frame: From Day 0 to month 12
Safety profile of HEMO2life® post transplant
Time frame: From organ preservation to month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 38979743Tingle SJ, Thompson ER, Figueiredo RS, Moir JA, Goodfellow M, Talbot D, Wilson CH. Normothermic and hypothermic machine perfusion preservation versus static cold storage for deceased donor kidney transplantation. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD011671. doi: 10.1002/14651858.CD011671.pub3.
- Derived from this study: PubMed 37127632Le Meur Y, Nowak E, Barrou B, Thierry A, Badet L, Buchler M, Rerolle JP, Golbin L, Duveau A, Dantal J, Merville P, Kamar N, Demini L, Zal F. Evaluation of the efficacy of HEMO2life(R), a marine OXYgen carrier for Organ Preservation (OxyOp2) in renal transplantation: study protocol for a multicenter randomized trial. Trials. 2023 May 1;24(1):302. doi: 10.1186/s13063-023-07302-3.
- 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
Principal Investigator and Nephrology coordinator
Benoit BARROU principal investigator
Urology coordinator
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kidney transplant in people with End Stage Renal Diseases, run by University Hospital, Brest at 32 sites 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 7 inclusion and 3 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: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of HEMO2life® as an additive to standard organ preservation solution to prevent delayed graft function following renal transplantation. (time frame: From day 0 to day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04181710, which also lists 2 linked publications.
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 29 Nov 2023.