NCT04478968

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
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Wroclaw Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
OTHER	presence of AVF	Functioning AVF may have cardiotoxic potential

Timeline

• Start date: 2020-01-03
• Primary completion: 2022-01-02
• Completion: 2022-01-02
• First posted: 2020-07-21
• Last updated: 2020-07-21

Locations

1 site across 1 country: Poland