Evaluation of a Marine OXYgen Carrier: HEMO2Life® for hypOthermic Kidney Graft Preservation, Before Transplantation (OXYOP)

Regional University Hospital Center (CHRU)

Status and phase: Completed; Phase 1

Conditions: End Stage Renal Diseases

Treatments: Procedure: HEMO2Life® use in organ preservation solution

Study type: Interventional

Funder types: Other

Identifiers

NCT02652520

OXYOP (RB 14.208)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Kidney transplantation

Experimental group

Description:

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.

Treatment:

Procedure: HEMO2Life® use in organ preservation solution