Clinical trial NCT04181710: Evaluation of a Marine OXYgen Carrier for Organ Preservation
Official title: Evaluation of a Marine OXYgen Carrier for Organ Preservation : a Multicenter Randomized Study Evaluating the Efficacy of HEMO2life® Versus Standard of Care in Renal Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Diseases
Keywords: Kidney transplantation
Organ preservation
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-11-29
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility 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,

Primary outcomes:
measure: Efficacy of HEMO2life® as an additive to standard organ preservation solution to prevent delayed graft function following renal transplantation.
timeFrame: From day 0 to day 7
Secondary outcomes:
measure: Assess and compare graft and patient survival in the two groups.
timeFrame: From month 0 to month 12
measure: Efficacy of HEMO2life® on renal parameters compared with standard of care
timeFrame: From month 0 to month 12
measure: Efficacy in specific populations depending on type of donors and the type of preservation solution.
timeFrame: From month 0 to month 12
measure: Evaluate the impact of HEMO2Life® on the degree and progression of interstitial fibrosis on the pre-implantation and 3 month biopsies
timeFrame: biopsies pre-implantation and month 3
measure: Evaluate the impact of HEMO2life® on quality of life following renal transplant at Month-1, 3 and 12.
timeFrame: From Day 0 to month 12
measure: Safety profile of HEMO2life® post transplant
timeFrame: From organ preservation to month 12
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens
city: Angers
country: France
facility: Angers
city: Besançon
country: France
facility: Besançon
city: Bordeaux
country: France
facility: Bordeaux
city: Brest
country: France
facility: CHRU de Brest
city: Caen
country: France
facility: Caen
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand
city: Dijon
country: France
facility: Dijon
city: Grenoble
country: France
facility: Grenoble
city: Lille
country: France
facility: Lille
city: Limoges
country: France
facility: Limoges
city: Lyon
country: France
facility: Lyon
city: Marseille
country: France
facility: Marseille
city: Montpellier
country: France
facility: Montpellier
city: Nancy
country: France
facility: Nancy
city: Nantes
country: France
facility: Nantes
city: Nice
country: France
facility: Nice
city: Paris
country: France
facility: APHP Bicêtre
city: Paris
country: France
facility: APHP Henri Mondor
city: Paris
country: France
facility: APHP Necker
city: Paris
country: France
facility: APHP Saint-Louis
city: Paris
country: France
facility: Association Hopital Foch
city: Paris
country: France
facility: Paris La Salpétrière
city: Poitiers
country: France
facility: Poitiers
city: Reims
country: France
facility: Reims
city: Rennes
country: France
facility: Rennes
city: Rouen
country: France
facility: Rouen
city: Saint-Denis
country: France
facility: La Réunion
city: Saint-Étienne
country: France
facility: Saint-Etienne
city: Strasbourg
country: France
facility: Strasbourg
city: Toulouse
country: France
facility: Toulouse
city: Tours
country: France
facility: 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: