Evaluation of HEMO2Life® for Kidney Graft Preservation (O... | NCT05050513

Studies
Evaluation of HEMO2Life® for Kidney Graft Preservation (OXYOP): 4 Years Follow-up

NCT05050513

Sponsor

University Hospital, Brest

Status

Unknown status

Last Update Posted

Sep 20, 2021Actual

Enrollment

116Estimated

Phase

Not provided

Conditions

Transplant; Complication, Failure

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2021Actual

Primary Completion Date

Oct 2021Estimated

Completion Date

Oct 2021Estimated

First Submitted Date

Jul 6, 2021

First Submission Date that Met QC Criteria

Sep 17, 2021

First Posted Date

Sep 20, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2021

Last Update Posted Date

Sep 20, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

4 years follow-up of the oxyop study.

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). We also analyzed some efficacy secondary end points using a paired analysis (local kidney receiving HEMO2life® versus contralateral kidney transplanted elsewhere in France). Oxyop4 aims to analyse 4 years results.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

116Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
interventional group		kidney graft preserved with M101
control group		kident graft preserved in standard condition (without M101)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
eGFR	estimated GFR (CKDEPI)	4 years

Secondary Outcomes

Measure	Description	Time Frame
patient survival	patient survival at last follow-up	4 years
graft survival	graft survival at last follow-up	4 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

informed patients participating to the oxyop study

Exclusion Criteria:

patients refusing to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

116 patients previously included in the oxyop study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yannick Le Meur, MD, PhD	Contact	02.98.34.70.74		yannick.lemeur@chu-brest.fr
Christelle Ratajczak	Contact	02.98.34.70.61		christelle.ratajaczak@chu-brest.fr

Overall Officials

Name	Affiliation	Role
Yannick le Meur	University hospital Brest France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Brest	Recruiting	Brest		29609	France

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All collected data that underlie results in a publication.

Types

Study Protocol

Time Frame

Data will be available beginning three years and ending five years following the final study report completion.

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

URL

Not provided