Approach to Vascular Access After Renal Transplantation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Other: presence of AVF


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active AVF<br>Patients after kidney transplantation with functioning AVF | Other: presence of AVF<br>* Functioning AVF may have cardiotoxic potential<br>|
| No AVF<br>Patients after kidney transplantation without AVF (thrombosed AVF, history of HD with catheter, history of PD, preemptive transplantation) | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arteriovenous Fistula