Evaluation of a Marine OXYgen Carrier for Organ Preservation

Not Applicable

Completed

• Conditions: End Stage Renal Diseases
• Interventions: Procedure: Kidney transplant

• Registration Number: NCT04181710
• Lead Sponsor: University Hospital, Brest

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-27
• Study First Submitted QC: 2019-11-27
• Study First Posted: 2019-11-29
• Study Start: 2020-07-04
• Primary Completion: 2022-07-12
• Study Completion: 2023-09-11
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 490

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,

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Kidney transplant	Organ preserved in preservation solution routinely used according to the local practice
HEMO2life	Kidney transplant	HEMO2life® will be used for ex vivo graft preservation at the dose of 1g per liter of preservation solution.

Primary Outcome Measures

Name	Time	Method
Efficacy of HEMO2life® as an additive to standard organ preservation solution to prevent delayed graft function following renal transplantation.	From day 0 to day 7	Delayed graft function defined as the requirement for dialysis during the first week after transplantation will be compared as per the confirmatory testing strategy

Secondary Outcome Measures

Name	Time	Method
Efficacy of HEMO2life® on renal parameters compared with standard of care	From month 0 to month 12	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)
Efficacy in specific populations depending on type of donors and the type of preservation solution.	From month 0 to month 12	Rate of primary non function
Evaluate the impact of HEMO2Life® on the degree and progression of interstitial fibrosis on the pre-implantation and 3 month biopsies	biopsies pre-implantation and month 3	Rate of biopsy-proven acute rejection at one year
Evaluate the impact of HEMO2life® on quality of life following renal transplant at Month-1, 3 and 12.	From Day 0 to month 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.
Assess and compare graft and patient survival in the two groups.	From month 0 to month 12	Graft and patient survival at one year
Safety profile of HEMO2life® post transplant	From organ preservation to month 12	Safety profile of HEMO2life® post transplant based on 3 analysis : graft safety, recipient safety, graft function

Trial Locations

Locations (32)

Amiens; 🇫🇷 Amiens, France

La Réunion; 🇫🇷 Saint-Denis, France

Dijon; 🇫🇷 Dijon, France

Angers; 🇫🇷 Angers, France

Bordeaux; 🇫🇷 Bordeaux, France

Besançon; 🇫🇷 Besançon, France

CHRU de Brest; 🇫🇷 Brest, France

Caen; 🇫🇷 Caen, France

Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Limoges; 🇫🇷 Limoges, France

Grenoble; 🇫🇷 Grenoble, France

Lille; 🇫🇷 Lille, France

Marseille; 🇫🇷 Marseille, France

Lyon; 🇫🇷 Lyon, France

Montpellier; 🇫🇷 Montpellier, France

Nantes; 🇫🇷 Nantes, France

Nice; 🇫🇷 Nice, France

Nancy; 🇫🇷 Nancy, France

APHP Bicêtre; 🇫🇷 Paris, France

APHP Henri Mondor; 🇫🇷 Paris, France

APHP Necker; 🇫🇷 Paris, France

APHP Saint-Louis; 🇫🇷 Paris, France

Poitiers; 🇫🇷 Poitiers, France

Association Hopital Foch; 🇫🇷 Paris, France

Paris La Salpétrière; 🇫🇷 Paris, France

Reims; 🇫🇷 Reims, France

Rennes; 🇫🇷 Rennes, France

Strasbourg; 🇫🇷 Strasbourg, France

Toulouse; 🇫🇷 Toulouse, France

Saint-Etienne; 🇫🇷 Saint-Étienne, France

Rouen; 🇫🇷 Rouen, France

Tours; 🇫🇷 Tours, France