Evaluation at 5 and 10 Years of Renal Transplant Patients

Transplant; Complication, Failure Clinical Trial

— OXYOP 5 and 10  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05469906
• Other study ID #: OXYOP 5 and 10 (29BRC22.0144)
• Status: Not yet recruiting
• Start date: July 2022
• Est. completion date: December 2027

Study information

• Verified date: July 2022
• 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

5 and 10 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). 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 116
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Transplant; Complication, Failure

Locations

Country	Name	City	State
France	CHRU 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)	10 years
Secondary	patient survival	patient survival at last follow-up	5 and 10 years
Secondary	graft survival	graft survival at last follow-up	5 and 10 years
Secondary	rejection rate	biopsy proven rejection	5 and 10 years
Secondary	infection rate	all infection episodes	5 and 10 years
Secondary	hospitalization	number of hospitalization, hospital stay	5 and 10 years