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

Transplant; Complication, Failure Clinical Trial

— OXYOP4  

Official title:

Evaluation of a Marine OXYgen Carrier (HEMO2Life®) for hypOthermic Kidney Graft Preservation Before Transplantation (OXYOP): 4 Years Follow-up

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05050513
• Other study ID #: 229BRC21.0097
• Status: Recruiting
• Start date: May 1, 2021
• Est. completion date: October 2021

Study information

• Verified date: July 2021
• Source: University Hospital, Brest
• Contact: Yannick Le Meur, MD, PhD
• Phone: 02.98.34.70.74
• Email: yannick.lemeur[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

4 years follow-up of the oxyop study.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• informed patients participating to the oxyop study

Exclusion Criteria:

• patients refusing to participate

Related Conditions & MeSH terms

• Transplant; Complication, Failure

Locations

Country	Name	City	State
France	CHU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	eGFR	estimated GFR (CKDEPI)	4 years
Secondary	patient survival	patient survival at last follow-up	4 years
Secondary	graft survival	graft survival at last follow-up	4 years
Secondary	rejection rate	biopsy proven rejection	4 years
Secondary	infection rate	all infection episodes	4 years
Secondary	hospitalization	number of hospitalization, hospital stay	4 years