Clinical trial NCT02652520: Evaluation of a Marine OXYgen Carrier: HEMO2Life® for hypOthermic Kidney Graft Preservation, Before Transplantation (OXYOP)
Official title: Evaluation of a Marine OXYgen Carrier: HEMO2Life® for hypOthermic Kidney Graft Preservation, Before Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: End Stage Renal Diseases
Keywords: Kidney transplantation
Organ preservation
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-01-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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 :

1. HEMO2Life® adverse effects
2. graft safety
3. recipient safety (any adverse event) Accountability search will be achieved for each of these events.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Graft from a living donor
* Graft from a donor after cardiovascular death (DCD)
* Graft dedicated to a multi-organ transplantation

Primary outcomes:
measure: HEMO2Life® adverse effects
timeFrame: During 3 months
measure: Graft safety
timeFrame: During 3 months
measure: Recipient safety (any adverse event)
timeFrame: During 3 months
Secondary outcomes:
measure: Comparison of the graft survival criteria with a control population
timeFrame: Baseline to 12 months
measure: Histological evaluation of the graft on biopsies
timeFrame: pre-implantation to 3-month biopsies
measure: Analysis of markers involved in kydney regeneration and neovascularization and markers of cellular stress.
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU Brest
city: Limoges
country: France
facility: CHU Limoges
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Paris
country: France
facility: Hôpital la Pitié Salpetrière
city: Poitiers
country: France
facility: CHU Poitiers
city: Tours
country: France
facility: CHRU de Tours
Study officials:
affiliation: Principal Investigator and Nephrology coordinator
name: Yannick LE MEUR
role: PRINCIPAL_INVESTIGATOR
affiliation: Urology coordinator
name: Benoit BARROU
role: PRINCIPAL_INVESTIGATOR
References: