Evaluation of a Marine OXYgen Carrier for Organ Preservation

NCT04181710 | Completed DMC

• 1 other identifier: OXYOP 2 (29BRC19.0048)
• Study Type: interventional
• Target: 490
• Locations: 1 country
• Sites: 32

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.

Conditions

End Stage Renal Diseases

Keywords

Kidney transplantation; Organ preservation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Assess and compare graft and patient survival in the two groups.

  From month 0 to month 12

• Efficacy of HEMO2life® on renal parameters compared with standard of care

  From month 0 to month 12

• Efficacy in specific populations depending on type of donors and the type of preservation solution.

  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

  biopsies pre-implantation and month 3

• Evaluate the impact of HEMO2life® on quality of life following renal transplant at Month-1, 3 and 12.

  From Day 0 to month 12

Study Arms (2)

HEMO2life

EXPERIMENTAL

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

Procedure: Kidney transplant

Control

OTHER

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

Procedure: Kidney transplant

Interventions

Kidney transplant PROCEDURE

Organ preserved in preservation solution

Control; HEMO2life

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (32)

Amiens

Amiens, France

Location

Angers

Angers, France

Location

Besançon

Besançon, France

Location

Bordeaux

Bordeaux, France

Location

CHRU de Brest

Brest, France

Location

Caen

Caen, France

Location

Clermont-Ferrand

Clermont-Ferrand, France

Location

Dijon

Dijon, France

Location

Grenoble

Grenoble, France

Location

Lille

Lille, France

Location

Limoges

Limoges, France

Location

Lyon

Lyon, France

Location

Marseille

Marseille, France

Location

Montpellier

Montpellier, France

Location

Nancy

Nancy, France

Location

Nantes

Nantes, France

Location

Nice

Nice, France

Location

APHP Bicêtre

Paris, France

Location

APHP Henri Mondor

Paris, France

Location

APHP Necker

Paris, France

Location

APHP Saint-Louis

Paris, France

Location

Association Hopital Foch

Paris, France

Location

Paris La Salpétrière

Paris, France

Location

Poitiers

Poitiers, France

Location

Reims

Reims, France

Location

Rennes

Rennes, France

Location

Rouen

Rouen, France

Location

La Réunion

Saint-Denis, France

Location

Saint-Etienne

Saint-Etienne, France

Location

Strasbourg

Strasbourg, France

Location

Toulouse

Toulouse, France

Location

Tours

Tours, France

Location

Related Publications (2)

• Tingle SJ, Thompson ER, Figueiredo RS, Moir JA, Goodfellow M, Talbot D, Wilson CH. Normothermic and hypothermic machine perfusion preservation versus static cold storage for deceased donor kidney transplantation. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD011671. doi: 10.1002/14651858.CD011671.pub3.

  PMID: 38979743 DERIVED

• Le Meur Y, Nowak E, Barrou B, Thierry A, Badet L, Buchler M, Rerolle JP, Golbin L, Duveau A, Dantal J, Merville P, Kamar N, Demini L, Zal F. Evaluation of the efficacy of HEMO2life(R), a marine OXYgen carrier for Organ Preservation (OxyOp2) in renal transplantation: study protocol for a multicenter randomized trial. Trials. 2023 May 1;24(1):302. doi: 10.1186/s13063-023-07302-3.

  PMID: 37127632 DERIVED

MeSH Terms

Interventions

Kidney Transplantation

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Organ Transplantation; Transplantation; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Yannick LE MEUR

  Principal Investigator and Nephrology coordinator

  PRINCIPAL INVESTIGATOR

• Benoit BARROU

  Urology coordinator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: November 29, 2019
• Study Start: July 4, 2020
• Primary Completion: July 12, 2022
• Study Completion: September 11, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• 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.

Locations

FR (32)