Evaluation of a Marine OXYgen Carrier for Organ Preservation

End Stage Renal Diseases Clinical Trial

— OXYOP 2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04181710
• Other study ID #: OXYOP 2 (29BRC19.0048)
• Status: Completed
• Phase: N/A
• Start date: July 4, 2020
• Est. completion date: September 11, 2023

Study information

• Verified date: November 2023
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 490
• Est. completion date: September 11, 2023
• Est. primary completion date: July 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• End Stage Renal Diseases
• Kidney Failure, Chronic

Intervention

Procedure:
• Kidney transplant
Organ preserved in preservation solution

Locations

Country	Name	City	State
France	Amiens	Amiens
France	Angers	Angers
France	Besançon	Besançon
France	Bordeaux	Bordeaux
France	CHRU de Brest	Brest
France	Caen	Caen
France	Clermont-Ferrand	Clermont-Ferrand
France	Dijon	Dijon
France	Grenoble	Grenoble
France	Lille	Lille
France	Limoges	Limoges
France	Lyon	Lyon
France	Marseille	Marseille
France	Montpellier	Montpellier
France	Nancy	Nancy
France	Nantes	Nantes
France	Nice	Nice
France	APHP Bicêtre	Paris
France	APHP Henri Mondor	Paris
France	APHP Necker	Paris
France	APHP Saint-Louis	Paris
France	Association Hopital Foch	Paris
France	Paris La Salpétrière	Paris
France	Poitiers	Poitiers
France	Reims	Reims
France	Rennes	Rennes
France	Rouen	Rouen
France	La Réunion	Saint-Denis
France	Saint-Etienne	Saint-Étienne
France	Strasbourg	Strasbourg
France	Toulouse	Toulouse
France	Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of HEMO2life® as an additive to standard organ preservation solution to prevent delayed graft function following renal transplantation.	Delayed graft function defined as the requirement for dialysis during the first week after transplantation will be compared as per the confirmatory testing strategy	From day 0 to day 7
Secondary	Assess and compare graft and patient survival in the two groups.	Graft and patient survival at one year	From month 0 to month 12
Secondary	Efficacy of HEMO2life® on renal parameters compared with standard of care	Evaluation using DGF assessed with alternative definitions: more than one dialysis session, need for dialysis except for hyperkaliemia or overhydration reason, time to reach a creatinine value of 250 µmol/l, DGF duration and using Renal function (creatinine value and eGFR)	From month 0 to month 12
Secondary	Efficacy in specific populations depending on type of donors and the type of preservation solution.	Rate of primary non function	From month 0 to month 12
Secondary	Evaluate the impact of HEMO2Life® on the degree and progression of interstitial fibrosis on the pre-implantation and 3 month biopsies	Rate of biopsy-proven acute rejection at one year	biopsies pre-implantation and month 3
Secondary	Evaluate the impact of HEMO2life® on quality of life following renal transplant at Month-1, 3 and 12.	Quality of life assess using the generic self-administered questionnaire EuroQol-5 Dimensions (EQ-5D) and a specific questionnaire for renal transplant recipients in the French language: the ReTransQol (RTQ) [0-100]. For RTQ, higher score mean a better outcome.	From Day 0 to month 12
Secondary	Safety profile of HEMO2life® post transplant	Safety profile of HEMO2life® post transplant based on 3 analysis : graft safety, recipient safety, graft function	From organ preservation to month 12