NCT02652520

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2016

Typical duration for phase_1

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 12, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2018

Completed
Last Updated

March 19, 2018

Status Verified

March 1, 2018

Enrollment Period

2 years

First QC Date

December 22, 2015

Last Update Submit

March 16, 2018

Conditions

End Stage Renal Diseases

Keywords

Kidney transplantationOrgan preservation

Outcome Measures

Primary Outcomes (3)

  • HEMO2Life® adverse effects

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

    During 3 months

  • Graft safety

    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.

    During 3 months

  • Recipient safety (any adverse event)

    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

    During 3 months

Secondary Outcomes (3)

  • Comparison of the graft survival criteria with a control population

    Baseline to 12 months

  • Histological evaluation of the graft on biopsies

    pre-implantation to 3-month biopsies

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

    Baseline to 12 months

Study Arms (1)

Kidney transplantation

EXPERIMENTAL

HEMO2Life® use in organ preservation solution. Grafts removed and transplanted locally within the 6 kidney transplant centers participating in the study will be preserved with Hemo2life.

Procedure: HEMO2Life® use in organ preservation solution

Interventions

HEMO2Life® use in organ preservation solutionPROCEDURE

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.

Kidney transplantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For Kidney :

You may not qualify if:

  • 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.
  • Patient \> 18 years old
  • Graft from a living donor
  • Graft from a donor after cardiovascular death (DCD)
  • Graft dedicated to a multi-organ transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CHRU Brest

Brest, 29200, France

Location

CHU Limoges

Limoges, 87042, France

Location

Hôpital Edouard Herriot

Lyon, 69003, France

Location

Hôpital la Pitié Salpetrière

Paris, 75013, France

Location

CHU Poitiers

Poitiers, 86021, France

Location

CHRU de Tours

Tours, 37044, France

Location

Study Officials

  • Yannick LE MEUR

    Principal Investigator and Nephrology coordinator

    PRINCIPAL INVESTIGATOR

  • Benoit BARROU

    Urology coordinator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2015

First Posted

January 12, 2016

Study Start

March 1, 2016

Primary Completion

February 23, 2018

Study Completion

February 23, 2018

Last Updated

March 19, 2018

Record last verified: 2018-03

Locations

FR(6)