Evaluation of a Marine OXYgen Carrier for Organ Preservation

• Kidney transplant (Procedure): Organ preserved in preservation solution

Primary outcomes

• 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 outcomes

• Assess and compare graft and patient survival in the two groups. [From month 0 to month 12]: Graft and patient survival at one year
• 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.
• 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

Sex: All, ages: 18 Years to any

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,

• Results publication: 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
• Results publication: 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

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