Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-29 @ 9:28 AM
Study NCT ID:
NCT04478968
Status:
UNKNOWN
Last Update Posted:
2020-07-21
First Post:
2020-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Approach to Vascular Access After Renal Transplantation
Sponsor:
Wroclaw Medical University
Organization:
Study Overview
Official Title:
The Levels of Fibrosis Biomarkers in Patients After Renal Transplantation in Relation to Arteriovenous Fistula Function
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AVART
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: