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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02652520
First Posted: January 12, 2016
Last Update Posted: September 12, 2017
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.
Information provided by (Responsible Party):
University Hospital, Brest
  Purpose

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 Intervention Phase
End Stage Renal Diseases Procedure: HEMO2Life® use in organ preservation solution Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Brest:

Primary Outcome Measures:
  • HEMO2Life® adverse effects [ Time Frame: During 3 months ]
    All incidents and events of interest occurring during the use of HEMO2Life® will be collected

  • 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.

  • 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:
  • 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.

  • 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.

  • 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.


Enrollment: 60
Actual Study Start Date: March 2016
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
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
Principal Investigator: Yannick LE MEUR Principal Investigator and Nephrology coordinator
Principal Investigator: Benoit BARROU Urology coordinator
  More Information

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02652520     History of Changes
Other Study ID Numbers: OXYOP (RB 14.208)
First Submitted: December 22, 2015
First Posted: January 12, 2016
Last Update Posted: September 12, 2017
Last Verified: September 2017

Keywords provided by University Hospital, Brest:
Kidney transplantation
Organ preservation

Additional relevant MeSH terms:
Kidney Failure, Chronic
Hypothermia
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Body Temperature Changes
Signs and Symptoms
Pharmaceutical Solutions