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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
490
Organ preserved in preservation solution
Amiens
Amiens, France
Angers
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
...and 22 more locations
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
Time frame: From day 0 to day 7
Assess and compare graft and patient survival in the two groups.
Graft and patient survival at one year
Time frame: From month 0 to month 12
Efficacy of HEMO2life® on renal parameters compared with standard of care
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)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: From organ preservation to month 12
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