Evaluation at 5 and 10 Years of Renal Transplant Patients (OXYOP 5 and 10)

Evaluation at 5 and 10 Years of Renal Transplant Patients Who Received a Graft Preserved in a Solution HEMO2life®

5 and 10 years follow-up of the oxyop study.

Study Overview

• Status: Not yet recruiting
• Conditions: Transplant; Complication, Failure

Detailed Description

Oxyop (NCT02652520 PHRC) was a safety study evaluating the use of an oxygen carrier HEMO2life® as an additive in organ preservation solution in 60 transplanted kidneys. This was a national multicenter (6 centers) open-labeled safety study on HEMO2life® that included 58 recipients. The first patient was included on March 24th, 2016 and the study was completed on February 23th, 2018 (1 year of recruitment and 1 year of follow-up). Some efficacy secondary end points using a paired analysis was also analyzed (local kidney receiving HEMO2life® versus contralateral kidney transplanted elsewhere in France). Oxyop 5 and 10 years aims to analyse 5 and 10 years results.

• Study Type: Observational
• Enrollment (Anticipated): 116

Contacts and Locations

• Study Contact: Name: Yannick Le Meur, MD, PhD; Phone Number: 02.98.34.70.74; Email: yannick.lemeur@chu-brest.fr
• Study Contact Backup: Name: Christelle Ratajczak; Phone Number: 02.98.34.70.61; Email: christelle.ratajaczak@chu-brest.fr

Study Locations

• France
  • Brest, France, 29200
    • CHRU Brest
    • Contact: Yannick Le Meur; Email: yannick.lemeur@chu-brest.fr
    • Contact: Christelle RATAJCZAK; Email: christelle.ratajczak@chu-brest.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

116 patients previously included in the oxyop study

Description

Inclusion Criteria:

• informed patients participating to the oxyop study
• Patient having completed the OXYOP M12 follow-up visit
• Patient agreeing to participate in the observational study

Exclusion Criteria:

• Opposition to the use his medical data
• patient deceased or with graft lost before M48

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
interventional group; kidney graft preserved with M101
control group; kidney graft preserved in standard condition (without M101)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
eGFR	estimated GFR (CKDEPI)	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient survival	patient survival at last follow-up	5 and 10 years
graft survival	graft survival at last follow-up	5 and 10 years
rejection rate	biopsy proven rejection	5 and 10 years
infection rate	all infection episodes	5 and 10 years
hospitalization	number of hospitalization, hospital stay	5 and 10 years

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Yannick le Meur, University hospital Brest France

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): December 1, 2027
• Study Completion (Anticipated): December 1, 2027

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 22, 2022

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: renal transplantation; organ preservation; oxygen carrier
• Other Study ID Numbers: OXYOP 5 and 10 (29BRC22.0144)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All collected data that underlie results in a publication.
• IPD Sharing Time Frame: Data will be available beginning three years and ending five years following the final study report completion.
• IPD Sharing Access Criteria: Data access request will be reviewed by the internal committee of Brest University Hospital. Requestor will be required to sign and complete a data access agreement
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No