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

November 28, 2023 updated by: University Hospital, Brest

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

490

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HEMO2life
HEMO2life® will be used for ex vivo graft preservation at the dose of 1g per liter of preservation solution.
Procedure: Kidney transplant
Organ preserved in preservation solution
Other: Control
Organ preserved in preservation solution routinely used according to the local practice
Procedure: Kidney transplant
Organ preserved in preservation solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of HEMO2life® as an additive to standard organ preservation solution to prevent delayed graft function following renal transplantation.
Time Frame: 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
From day 0 to day 7

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

  • Principal Investigator: Yannick LE MEUR, Principal Investigator and Nephrology coordinator
  • Principal Investigator: Benoit BARROU, Urology coordinator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2020

Primary Completion (Actual)

July 12, 2022

Study Completion (Actual)

September 11, 2023

Study Registration Dates

First Submitted

November 27, 2019

First Submitted That Met QC Criteria

November 27, 2019

First Posted (Actual)

November 29, 2019

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OXYOP 2 (29BRC19.0048)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available beginning three years and ending fifteen years following the final study report completion

IPD Sharing Access Criteria

Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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