Approach to Vascular Access After Renal Transplantation

• Conditions: Kidney Transplantation
• Interventions: Other: presence of AVF

• Registration Number: NCT04478968
• Lead Sponsor: Wroclaw Medical University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-01-03
• Status Verified: 2020-06
• Study First Submitted: 2020-06-29
• Study First Submitted QC: 2020-07-15
• Last Update Submitted: 2020-07-15
• Study First Posted: 2020-07-21
• Last Update Posted: 2020-07-21
• Primary Completion: 2022-01-02
• Study Completion: 2022-01-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Active AVF	presence of AVF	Patients after kidney transplantation with functioning AVF

Primary Outcome Measures

Name	Time	Method
Quality of life with EQ-5D-5L	Baseline visit up to 12 months	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.
Prognostic value of biomarkers (NT-proBNP, Il-6, sST2, galectin-3, GDF-15, MMP7, TIMP1)	Baseline visit and up to 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Hospitalization-free survival	Up to 12 months from baseline visit	Hospital-free survival will be reported as the number of patients living 12 months after the initial visit without the need for hospitalization.

Trial Locations

Locations (1)

Department of Nephrology and Transplantation Medicine; 🇵🇱 Wroclaw, Poland