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NCT Number: NCT04181710

Evaluation of a Marine OXYgen Carrier for Organ Preservation

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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Key information

Conditions

End Stage Renal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Kidney Transplant

Procedure

Organ preserved in preservation solution

Primary outcomes

  1. Efficacy of HEMO2life® as an additive to standard organ preservation solution to prevent delayed graft function following renal transplantation.

    Time frame: 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

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

    Time frame: From month 0 to month 12

    Graft and patient survival at one year

  2. Efficacy of HEMO2life® on renal parameters compared with standard of care

    Time frame: 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)

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

    Time frame: From month 0 to month 12

    Rate of primary non function

  4. Evaluate the impact of HEMO2Life® on the degree and progression of interstitial fibrosis on the pre-implantation and 3 month biopsies

    Time frame: biopsies pre-implantation and month 3

    Rate of biopsy-proven acute rejection at one year

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

    Time frame: 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.

  6. Safety profile of HEMO2life® post transplant

    Time frame: From organ preservation to month 12

    Safety profile of HEMO2life® post transplant based on 3 analysis : graft safety, recipient safety, graft function

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

Evaluation of a Marine OXYgen Carrier for Organ Preservation : a Multicenter Randomized Study Evaluating the Efficacy of HEMO2life® Versus Standard of Care in Renal Transplantation

Acronym: OXYOP 2

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Nov 29, 2019
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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