Approach to Vascular Access After Renal Transplantation

Kidney Transplantation Clinical Trial

— AVART  

Official title:

The Levels of Fibrosis Biomarkers in Patients After Renal Transplantation in Relation to Arteriovenous Fistula Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04478968
• Other study ID #: MINI.C160.20.001
• Status: Recruiting
• Start date: January 3, 2020
• Est. completion date: January 2, 2022

Study information

• Verified date: June 2020
• Source: Wroclaw Medical University
• Contact: Krzysztof Letachowicz, MD, PhD
• Phone: +48717332546
• Email: krzysztof.letachowicz[@]umed.wroc.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the project is to assess the effect of functioning AVF in renal transplant patients on fibrosis, inflammation and LVH indicators. Clinical and laboratory parameters will be compared in a group of 150 patients, 75 patients with a functioning fistula and 75 patients with inactive vascular access. We will assess the impact of functional AVF and the levels of biomarkers on the survival of patients and transplanted kidneys.

Description:

Patients after kidney transplantation during a routine visit will be asked to participate to the study. In eligible a number of studies will be conducted:

• detailed clinical examination

• routine laboratory tests

• lung ultrasound

• muscle strength with a dynamometer

• ultrasound assessment of upper limb vessels with assessment of fistula function (in the case of active fistula) and for the possibility of future vascular access

• blood collection and protection (10-15 ml) for biomarkers

• survey EQ-5D-5L and LVD-36

• functional strength test.

The obtained clinical data and test results will be subject to statistical analysis after anonymization. The impact of individual parameters on long-term prognosis will be assessed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 2, 2022
• Est. primary completion date: January 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age> 18 years old

• kidney transplant

• >12 months after transplantation

• stable transplanted kidney function

• signed informed consent

Exclusion Criteria:

• GFR <15 ml / min

• severe infection within 3 months of testing

• increase in creatinine concentration> 0.5 mg / dl within 3 months before the test

• active cancer

• signs of severe heart failure (NYHA IV)

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Kidney Transplantation

Intervention

Other:
• presence of AVF
Functioning AVF may have cardiotoxic potential

Locations

Country	Name	City	State
Poland	Department of Nephrology and Transplantation Medicine	Wroclaw

Sponsors (1)

Lead Sponsor	Collaborator
Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life with EQ-5D-5L	The survey results will be compared between the study and control groups to see if the presence of the arteriovenous fistula affects quality of life.	Baseline visit up to 12 months
Primary	Prognostic value of biomarkers (NT-proBNP, Il-6, sST2, galectin-3, GDF-15, MMP7, TIMP1)	The levels of biomarkers will be measured and the results will be compared between the study and control groups. A prognostic value of the biomarkers will be estimated.	Baseline visit and up to 12 months
Secondary	Hospitalization-free survival	Hospital-free survival will be reported as the number of patients living 12 months after the initial visit without the need for hospitalization.	Up to 12 months from baseline visit