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Approach to Vascular Access After Renal Transplantation

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04478968
Acronym
AVART
Enrollment
150
Registered
2020-07-21
Start date
2020-01-03
Completion date
2022-01-02
Last updated
2020-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

Keywords

Arteriovenous Fistula

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.

Interventions

OTHERpresence of AVF

Functioning AVF may have cardiotoxic potential

Sponsors

Wroclaw Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Quality of life with EQ-5D-5LBaseline visit up to 12 monthsThe 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 monthsThe 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

MeasureTime frameDescription
Hospitalization-free survivalUp to 12 months from baseline visitHospital-free survival will be reported as the number of patients living 12 months after the initial visit without the need for hospitalization.

Countries

Poland

Contacts

Primary ContactKrzysztof Letachowicz, MD, PhD
krzysztof.letachowicz@umed.wroc.pl+48717332546

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026