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NCT Number: NCT02652520

Evaluation of a Marine OXYgen Carrier: HEMO2Life® for hypOthermic Kidney Graft Preservation, Before Transplantation (OXYOP)

Kidney transplantation is the treatment of choice for end stage renal diseases, increasing life expectancy and quality of life. Improvement in organ preservation is a critical issue in this context.

This is a safety study evaluating the use of an oxygen carrier HEMO2Life® as an additive in organ 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

Phase 1

Primary location

CHRU Brest, Brest, France

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About this study

Security of the use of HEMO2Life® will be analyzed by collecting all events within the first 3 months in terms of :

  • HEMO2Life® adverse effects
  • graft safety
  • recipient safety (any adverse event) Accountability search will be achieved for each of these events.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

For Kidney :

The first ten local kidneys in each participating centers that do not meet the exclusion criteria.

  • Graft retrieved in an adult donor
  • Graft from a deceased donor after brain death (DBD)
  • Graft locally transplanted in one of the 6 kidney transplant centers participating in the study
  • Graft stored in preservation solution containing HEMO2Life®

For Patient :

Patient who signed an inform consent form In case of patient unable to signed an inform consent form for patient under judicial protection (supervision, guardianship) the inform consent form will be obtain from the patient himself and from the supervisor/guardianshiper/parents, they will signed together the patient inform consent form.

The probability of the inclusion of a patient unable to signed an inform consent form is low but we can't know the receiver before conditioning the graft.

Patient > 18 years old

Exclusion criteria

  • Graft from a living donor
  • Graft from a donor after cardiovascular death (DCD)
  • Graft dedicated to a multi-organ transplantation

Treatment and study plan

HEMO2Life® use in organ preservation solution

Procedure

The surgeon decides whether the local transplant kidney may be part of the study and whether it should be stored in static cold storage or machine perfusion. The transplant kidney will be perfused in situ before procurement with the Belzer UW® cold storage solution furnish by the BridgetoLife company. HEMO2Life® will then be added to preservation solution.

Primary outcomes

  1. HEMO2Life® adverse effects

    Time frame: During 3 months

    All incidents and events of interest occurring during the use of HEMO2Life® will be collected

  2. Graft safety

    Time frame: During 3 months

    Collecting any complication with particular attention to mascroscopic aspect, contamination of the conservation solution, surgical difficulties and thrombosis, primary non function, delayed graft function, slow recovery of graft function, acute rejection, or any other graft complications.

  3. Recipient safety (any adverse event)

    Time frame: During 3 months

    All adverse events, even unrelated to HEMO2Life®, occuring during the first 3 months after transplantation will be collected. Vital signs and laboratory evaluations will be collected at D0, D1, D3, D7, D14, M1, M2 and M3 to evaluate the recipient safety

Secondary outcomes

  1. Comparison of the graft survival criteria with a control population

    Time frame: Baseline to 12 months

    Results will be compared with patients from a case control group of grafts transplanted at the same time in the 4 transplant centers from the Spiesser group (Tours, Poitiers, Brest, Limoges). Groups will be formed after matching on sex, age and cold ischemia time thanks to the Astre database regrouping the data of all the transplant teams from the Spiesser group.

  2. Histological evaluation of the graft on biopsies

    Time frame: pre-implantation to 3-month biopsies

    All biopsies are interpreted locally and classified according to the Banff classification. Interstitial fibrosis quantification using automated quantitative image analysis of biopsies will also be performed from each biopsy.

  3. Analysis of markers involved in kydney regeneration and neovascularization and markers of cellular stress.

    Time frame: Baseline to 12 months

    Analysis of blood and urine biomarkers at each visit.

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

Evaluation of a Marine OXYgen Carrier: HEMO2Life® for hypOthermic Kidney Graft Preservation, Before Transplantation

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 12, 2016
Registry last updated
Mar 19, 2018

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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