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

End Stage Renal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02652520
• Other study ID #: OXYOP (RB 14.208)
• Status: Completed
• Phase: Phase 1
• First received: December 22, 2015
• Last updated: March 16, 2018
• Start date: March 2016
• Est. completion date: February 23, 2018

Study information

• Verified date: March 2018
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 23, 2018
• Est. primary completion date: February 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Diseases
• Hypothermia
• Kidney Failure, Chronic

Intervention

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.

Locations

Country	Name	City	State
France	CHRU Brest	Brest
France	CHU Limoges	Limoges
France	Hôpital Edouard Herriot	Lyon
France	Hôpital la Pitié Salpetrière	Paris
France	CHU Poitiers	Poitiers
France	CHRU de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HEMO2Life® adverse effects	All incidents and events of interest occurring during the use of HEMO2Life® will be collected	During 3 months
Primary	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
Primary	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	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.	Baseline to 12 months
Secondary	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.	pre-implantation to 3-month biopsies
Secondary	Analysis of markers involved in kydney regeneration and neovascularization and markers of cellular stress.	Analysis of blood and urine biomarkers at each visit.	Baseline to 12 months