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

Phase 1

Completed

• Conditions: End Stage Renal Diseases
• Interventions: Procedure: HEMO2Life® use in organ preservation solution

• Registration Number: NCT02652520
• Lead Sponsor: University Hospital, Brest

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 :

1. HEMO2Life® adverse effects

2. graft safety

3. recipient safety (any adverse event) Accountability search will be achieved for each of these events.

Study Timeline

• Study First Submitted: 2015-12-22
• Study First Submitted QC: 2016-01-08
• Study First Posted: 2016-01-12
• Study Start: 2016-03
• Primary Completion: 2018-02-23
• Study Completion: 2018-02-23
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-16
• Last Update Posted: 2018-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Kidney transplantation	HEMO2Life® use in organ preservation solution	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.

Primary Outcome Measures

Name	Time	Method
HEMO2Life® adverse effects	During 3 months	All incidents and events of interest occurring during the use of HEMO2Life® will be collected
Graft safety	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)	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

Name	Time	Method
Histological evaluation of the graft on biopsies	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.
Comparison of the graft survival criteria with a control population	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.
Analysis of markers involved in kydney regeneration and neovascularization and markers of cellular stress.	Baseline to 12 months	Analysis of blood and urine biomarkers at each visit.

Trial Locations

Locations (6)

CHRU Brest; 🇫🇷 Brest, France

Hôpital la Pitié Salpetrière; 🇫🇷 Paris, France

CHU Limoges; 🇫🇷 Limoges, France

CHU Poitiers; 🇫🇷 Poitiers, France

CHRU de Tours; 🇫🇷 Tours, France

Hôpital Edouard Herriot; 🇫🇷 Lyon, France