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

Primary Purpose

End Stage Renal Diseases

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
HEMO2Life® use in organ preservation solution
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for End Stage Renal Diseases focused on measuring Kidney transplantation, Organ preservation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHRU Brest
  • CHU Limoges
  • Hôpital Edouard Herriot
  • Hôpital la Pitié Salpetrière
  • CHU Poitiers
  • CHRU de Tours

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Kidney transplantation

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Comparison of the graft survival criteria with a control population
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.
Histological evaluation of the graft on 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.
Analysis of markers involved in kydney regeneration and neovascularization and markers of cellular stress.
Analysis of blood and urine biomarkers at each visit.

Full Information

First Posted
December 22, 2015
Last Updated
March 16, 2018
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT02652520
Brief Title
Evaluation of a Marine OXYgen Carrier: HEMO2Life® for hypOthermic Kidney Graft Preservation, Before Transplantation (OXYOP)
Official Title
Evaluation of a Marine OXYgen Carrier: HEMO2Life® for hypOthermic Kidney Graft Preservation, Before Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
February 23, 2018 (Actual)
Study Completion Date
February 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Diseases
Keywords
Kidney transplantation, Organ preservation

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kidney transplantation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
HEMO2Life® use in organ preservation solution
Intervention Description
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 Outcome Measure Information:
Title
HEMO2Life® adverse effects
Description
All incidents and events of interest occurring during the use of HEMO2Life® will be collected
Time Frame
During 3 months
Title
Graft safety
Description
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.
Time Frame
During 3 months
Title
Recipient safety (any adverse event)
Description
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
Time Frame
During 3 months
Secondary Outcome Measure Information:
Title
Comparison of the graft survival criteria with a control population
Description
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.
Time Frame
Baseline to 12 months
Title
Histological evaluation of the graft on biopsies
Description
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.
Time Frame
pre-implantation to 3-month biopsies
Title
Analysis of markers involved in kydney regeneration and neovascularization and markers of cellular stress.
Description
Analysis of blood and urine biomarkers at each visit.
Time Frame
Baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yannick LE MEUR
Organizational Affiliation
Principal Investigator and Nephrology coordinator
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Benoit BARROU
Organizational Affiliation
Urology coordinator
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU Brest
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
CHU Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Hôpital la Pitié Salpetrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
CHU Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
CHRU de Tours
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

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

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