Evaluation of a Marine OXYgen Carrier: HEMO2Life® for hypOthermic Kidney Graft Preservation, Before Transplantation (OXYOP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02652520|
Recruitment Status : Completed
First Posted : January 12, 2016
Last Update Posted : March 19, 2018
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
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.
|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Diseases||Procedure: HEMO2Life® use in organ preservation solution||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of a Marine OXYgen Carrier: HEMO2Life® for hypOthermic Kidney Graft Preservation, Before Transplantation|
|Actual Study Start Date :||March 2016|
|Actual Primary Completion Date :||February 23, 2018|
|Actual Study Completion Date :||February 23, 2018|
Experimental: Kidney transplantation
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.
Procedure: HEMO2Life® use in organ preservation solution
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.
- 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
- Comparison of the graft survival criteria with a control population [ Time Frame: Baseline to 12 months ]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.
- Histological evaluation of the graft on biopsies [ Time Frame: pre-implantation to 3-month 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.
- Analysis of markers involved in kydney regeneration and neovascularization and markers of cellular stress. [ Time Frame: Baseline to 12 months ]Analysis of blood and urine biomarkers at each visit.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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®
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
- Graft from a living donor
- Graft from a donor after cardiovascular death (DCD)
- Graft dedicated to a multi-organ transplantation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02652520
|Brest, France, 29200|
|Limoges, France, 87042|
|Hôpital Edouard Herriot|
|Lyon, France, 69003|
|Hôpital la Pitié Salpetrière|
|Paris, France, 75013|
|Poitiers, France, 86021|
|CHRU de Tours|
|Tours, France, 37044|
|Principal Investigator:||Yannick LE MEUR||Principal Investigator and Nephrology coordinator|
|Principal Investigator:||Benoit BARROU||Urology coordinator|
|Responsible Party:||University Hospital, Brest|
|Other Study ID Numbers:||
OXYOP (RB 14.208)
|First Posted:||January 12, 2016 Key Record Dates|
|Last Update Posted:||March 19, 2018|
|Last Verified:||March 2018|
Kidney Failure, Chronic
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Male Urogenital Diseases
Renal Insufficiency, Chronic