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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HEMO2life | Experimental | HEMO2life® will be used for ex vivo graft preservation at the dose of 1g per liter of preservation solution. |
|
| Control | Other | Organ preserved in preservation solution routinely used according to the local practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kidney transplant | Procedure | Organ preserved in preservation solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assess and compare graft and patient survival in the two groups. | Graft and patient survival at one year | From month 0 to month 12 |
| Efficacy of HEMO2life® on renal parameters compared with standard of care |
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Inclusion Criteria:
Exclusion criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Yannick LE MEUR | Principal Investigator and Nephrology coordinator | Principal Investigator |
| Benoit BARROU | Urology coordinator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amiens | Amiens | France | ||||
| Angers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38979743 | Derived | 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. | |
| 37127632 | Derived |
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All collected data that underlie results in a publication
Data will be available beginning three years and ending fifteen years following the final study report completion
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.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 28, 2026 | |
| Reset | Jun 23, 2026 |
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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. | 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 | 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. | 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 | Safety profile of HEMO2life® post transplant based on 3 analysis : graft safety, recipient safety, graft function | From organ preservation to month 12 |
| 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-Etienne | France |
| Strasbourg | Strasbourg | France |
| Toulouse | Toulouse | France |
| Tours | Tours | France |
| 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 28, 2026 | Jun 23, 2026 | |||
| Jun 24, 2026 |
| ID | Term |
|---|---|
| D016030 | Kidney Transplantation |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016377 | Organ Transplantation |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
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