End Stage Renal DiseasesPhase 1NCT02652520
Evaluation of a Marine OXYgen Carrier: HEMO2Life® for hypOthermic Kidney Graft Preservation, Before Transplantation (OXYOP)
A Phase 1 study testing HEMO2Life® use in organ preservation solution in people with End Stage Renal Diseases, run by University Hospital, Brest at 6 sites in France.
Trial summary
Kidney transplantation is the treatment of choice for end stage renal diseases, increasing life expectancy and quality of life. Improvement in organ preservation is a critical issue in this context. 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?
- HEMO2Life® use in organ preservation solution
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesFrance
- Study dates
- Mar 2016to 23 Feb 2018
- Phase
- Phase 1
- 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 :
- The first ten local kidneys in each participating centers that do not meet the exclusion criteria.
- Graft retrieved in an adult donor
- Graft from a deceased donor after brain death (DBD)
- Graft locally transplanted in one of the 6 kidney transplant centers participating in the study
- Graft stored in preservation solution containing HEMO2Life®
Show all 10Show fewer
- For Patient :
- Patient who signed an inform consent form In case of patient unable to signed an inform consent form for patient under judicial protection (supervision, guardianship) the inform consent form will be obtain from the patient himself and from the supervisor/guardianshiper/parents, they will signed together the patient inform consent form.
- The probability of the inclusion of a patient unable to signed an inform consent form is low but we can't know the receiver before conditioning the graft.
- Patient > 18 years old
Who cannot join
- Graft from a living donor
- Graft from a donor after cardiovascular death (DCD)
- Graft dedicated to a multi-organ transplantation
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHRU Brest
Brest, 29200
CHU Limoges
Limoges, 87042
Hôpital Edouard Herriot
Lyon, 69003
Hôpital la Pitié Salpetrière
Paris, 75013
CHU Poitiers
Poitiers, 86021
CHRU de Tours
Tours, 37044
About this study
Official title: Evaluation of a Marine OXYgen Carrier: HEMO2Life® for hypOthermic Kidney Graft Preservation, Before Transplantation
Kidney transplantation is the treatment of choice for end stage renal diseases, increasing life expectancy and quality of life. Improvement in organ preservation is a critical issue in this context.
This is a safety study evaluating the use of an oxygen carrier HEMO2Life® as an additive in organ preservation solution in kidney transplantation.
Read the detailed description
Security of the use of HEMO2Life® will be analyzed by collecting all events within the first 3 months in terms of :
- HEMO2Life® adverse effects
- graft safety
- recipient safety (any adverse event) Accountability search will be achieved for each of these events.
- Conditions
- End Stage Renal Diseases
- Being tested
- HEMO2Life® use in organ preservation solution
- Keywords
- Kidney transplantation, Organ preservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEMO2Life® use in organ preservation solutionProcedure or surgery
The surgeon decides whether the local transplant kidney may be part of the study and whether it should be stored in static cold storage or machine perfusion. The transplant kidney will be perfused in situ before procurement with the Belzer UW® cold storage solution furnish by the BridgetoLife company. HEMO2Life® will then be added to preservation solution.
| Study group | Role | What they receive |
|---|---|---|
| Kidney transplantation | Experimental | HEMO2Life® use in organ preservation solution. Grafts removed and transplanted locally within the 6 kidney transplant centers participating in the study will be preserved with Hemo2life. Receives: Procedure: HEMO2Life® use in organ preservation solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
HEMO2Life® adverse effects
All incidents and events of interest occurring during the use of HEMO2Life® will be collected
Measured: During 3 months
Graft safety
Collecting any complication with particular attention to mascroscopic aspect, contamination of the conservation solution, surgical difficulties and thrombosis, primary non function, delayed graft function, slow recovery of graft function, acute rejection, or any other graft complications.
Measured: During 3 months
Recipient safety (any adverse event)
All adverse events, even unrelated to HEMO2Life®, occuring during the first 3 months after transplantation will be collected. Vital signs and laboratory evaluations will be collected at D0, D1, D3, D7, D14, M1, M2 and M3 to evaluate the recipient safety
Measured: During 3 months
Secondary outcomes (3)
Comparison of the graft survival criteria with a control population
Results will be compared with patients from a case control group of grafts transplanted at the same time in the 4 transplant centers from the Spiesser group (Tours, Poitiers, Brest, Limoges). Groups will be formed after matching on sex, age and cold ischemia time thanks to the Astre database regrouping the data of all the transplant teams from the Spiesser group.
Measured: Baseline to 12 months
Histological evaluation of the graft on biopsies
All biopsies are interpreted locally and classified according to the Banff classification. Interstitial fibrosis quantification using automated quantitative image analysis of biopsies will also be performed from each biopsy.
Measured: pre-implantation to 3-month biopsies
Analysis of markers involved in kydney regeneration and neovascularization and markers of cellular stress.
Analysis of blood and urine biomarkers at each visit.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startMar 2016
- Primary completion23 Feb 2018
- Study completion23 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT02652520
- Sponsor's protocol ID
- OXYOP (RB 14.208)
- Status last verified
- Mar 2018
- First submitted
- 22 Dec 2015
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. 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
- ClinicalTrials.gov ID
- NCT02652520
- Acronym / sponsor ID
- OXYOP (RB 14.208)
- Conditions
- End Stage Renal Diseases
- Keywords
- Kidney transplantation, Organ preservation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- 23 Feb 2018 (actual)
- Study completion
- 23 Feb 2018 (actual)
- First posted
- 12 Jan 2016 (estimated)
- 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.
Kidney transplantation is the treatment of choice for end stage renal diseases, increasing life expectancy and quality of life. Improvement in organ preservation is a critical issue in this context.
This is a safety study evaluating the use of an oxygen carrier HEMO2Life® as an additive in organ preservation solution in kidney transplantation.
Detailed description
Security of the use of HEMO2Life® will be analyzed by collecting all events within the first 3 months in terms of :
- HEMO2Life® adverse effects
- graft safety
- recipient safety (any adverse event) Accountability search will be achieved for each of these events.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney transplantation | Experimental | Procedure: HEMO2Life® use in organ preservation solutionHEMO2Life® use in organ preservation solution. Grafts removed and transplanted locally within the 6 kidney transplant centers participating in the study will be preserved with Hemo2life. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The first ten local kidneys in each participating centers that do not meet the exclusion criteria.
- Graft retrieved in an adult donor
- Graft from a deceased donor after brain death (DBD)
- Graft locally transplanted in one of the 6 kidney transplant centers participating in the study
- Graft stored in preservation solution containing HEMO2Life®
Key exclusion criteria (3 listed)
- Graft from a living donor
- Graft from a donor after cardiovascular death (DCD)
- Graft dedicated to a multi-organ 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 |
|---|---|---|
| HEMO2Life® use in organ preservation solutionThe surgeon decides whether the local transplant kidney may be part of the study and whether it should be stored in static cold storage or machine perfusion. The transplant kidney will be perfused in situ before procurement with the Belzer UW® cold storage solution furnish by the BridgetoLife company. HEMO2Life® will then be added to preservation solution. | Procedure or surgery | Kidney transplantation |
Primary outcome
HEMO2Life® adverse effects
Time frame: During 3 months
All incidents and events of interest occurring during the use of HEMO2Life® will be collected
Graft safety
Time frame: During 3 months
Collecting any complication with particular attention to mascroscopic aspect, contamination of the conservation solution, surgical difficulties and thrombosis, primary non function, delayed graft function, slow recovery of graft function, acute rejection, or any other graft complications.
Recipient safety (any adverse event)
Time frame: During 3 months
All adverse events, even unrelated to HEMO2Life®, occuring during the first 3 months after transplantation will be collected. Vital signs and laboratory evaluations will be collected at D0, D1, D3, D7, D14, M1, M2 and M3 to evaluate the recipient safety
3 secondary outcomes
Comparison of the graft survival criteria with a control population
Time frame: Baseline to 12 months
Histological evaluation of the graft on biopsies
Time frame: pre-implantation to 3-month biopsies
Analysis of markers involved in kydney regeneration and neovascularization and markers of cellular stress.
Time frame: Baseline to 12 months
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 19 Mar 2018.
Related trials for End Stage Renal Diseases
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Recruiting
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
End Stage Renal Disease
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
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HEMO2Life® use in organ preservation solution in people with End Stage Renal Diseases, run by University Hospital, Brest at 6 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 10 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 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
HEMO2Life® adverse effects (time frame: During 3 months). The study lists 3 primary outcomes in all. 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 19 Mar 2018.