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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02652520
Recruitment Status : Completed
First Posted : January 12, 2016
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Study Description
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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.


Condition or disease Intervention/treatment Phase
End Stage Renal Diseases Procedure: HEMO2Life® use in organ preservation solution Phase 1

Detailed Description:

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

  1. HEMO2Life® adverse effects
  2. graft safety
  3. recipient safety (any adverse event) Accountability search will be achieved for each of these events.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of a Marine OXYgen Carrier: HEMO2Life® for hypOthermic Kidney Graft Preservation, Before Transplantation
Actual Study Start Date : March 2016
Actual Primary Completion Date : February 23, 2018
Actual Study Completion Date : February 23, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Kidney transplantation
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
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02652520


Locations
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France
CHRU Brest
Brest, France, 29200
CHU Limoges
Limoges, France, 87042
Hôpital Edouard Herriot
Lyon, France, 69003
Hôpital la Pitié Salpetrière
Paris, France, 75013
CHU Poitiers
Poitiers, France, 86021
CHRU de Tours
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Brest
Investigators
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Principal Investigator: Yannick LE MEUR Principal Investigator and Nephrology coordinator
Principal Investigator: Benoit BARROU Urology coordinator
More Information
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02652520    
Other Study ID Numbers: OXYOP (RB 14.208)
First Posted: January 12, 2016    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Keywords provided by University Hospital, Brest:
Kidney transplantation
Organ preservation
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
 Male Urogenital Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Chronic Disease
Disease Attributes
Pathologic Processes