End Stage Renal Diseases
Conditions
Keywords
Kidney transplantation, Organ preservation
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.
Interventions
PROCEDUREKidney transplant
Organ preserved in preservation solution
Sponsors
University Hospital, Brest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Assess and compare graft and patient survival in the two groups. | From month 0 to month 12 | Graft and patient survival 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 |
| 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 |
Countries
France
Outcome results
None listed