Evaluation of a Marine OXYgen Carrier for Organ Preservation (OXYOP 2)

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: End Stage Renal Diseases

Treatments: Procedure: Kidney transplant

Study type: Interventional

Funder types: Other

Identifiers

NCT04181710

OXYOP 2 (29BRC19.0048)

Details and patient eligibility

About

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.

Enrollment: 490 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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

Exclusion criteria :

• For kidney :
• Graft from a living donor
• Graft dedicated to a multi-organ transplantation or dual kidney transplantation,

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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490 participants in 2 patient groups

HEMO2life

Experimental group

Description:

HEMO2life® will be used for ex vivo graft preservation at the dose of 1g per liter of preservation solution.

Treatment:

Procedure: Kidney transplant

Control

Other group

Description:

Organ preserved in preservation solution routinely used according to the local practice

Treatment:

Procedure: Kidney transplant