Approach to Vascular Access After Renal Transplantation (AVART)

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

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.

Study Overview

• Status: Unknown
• Conditions: Kidney Transplantation
• Intervention / Treatment: Other: presence of AVF

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Krzysztof Letachowicz, MD, PhD; Phone Number: +48717332546; Email: krzysztof.letachowicz@umed.wroc.pl

Study Locations

• Poland
  • Wroclaw, Poland, 55-556
    • Recruiting
    • Department of Nephrology and Transplantation Medicine
    • Contact: Krzysztof Letachowicz, MD, PhD; Phone Number: +48717332546; Email: krzysztof.letachowiocz@umed.wroc.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have had a kidney transplant belong to the group of patients at increased risk for cardiovascular disease.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Active AVF; Patients after kidney transplantation with functioning AVF	Other: presence of AVF; Functioning AVF may have cardiotoxic potential
No AVF; Patients after kidney transplantation without AVF (thrombosed AVF, history of HD with catheter, history of PD, preemptive transplantation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Wroclaw Medical University
• Investigators: Principal Investigator: Krzysztof Letachowicz, MD, PhD, Wroclaw Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2020
• Primary Completion (Anticipated): January 2, 2022
• Study Completion (Anticipated): January 2, 2022

Study Registration Dates

• First Submitted: June 29, 2020
• First Submitted That Met QC Criteria: July 15, 2020
• First Posted (Actual): July 21, 2020

Study Record Updates

• Last Update Posted (Actual): July 21, 2020
• Last Update Submitted That Met QC Criteria: July 15, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Arteriovenous Fistula
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: MINI.C160.20.001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No