Approach to Vascular Access After Renal Transplantation

NCT04478968 | Unknown

• 1 other identifier: MINI.C160.20.001
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplantation

Keywords

Arteriovenous Fistula

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Hospitalization-free survival

  Up to 12 months from baseline visit

Study Arms (2)

Active AVF

Patients after kidney transplantation with functioning AVF

Other: presence of AVF

No AVF

Patients after kidney transplantation without AVF (thrombosed AVF, history of HD with catheter, history of PD, preemptive transplantation)

Interventions

presence of AVF OTHER

Functioning AVF may have cardiotoxic potential

Active AVF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• age\> 18 years old
• kidney transplant
• \>12 months after transplantation
• stable transplanted kidney function
• signed informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

Department of Nephrology and Transplantation Medicine

Wroclaw, 55-556, Poland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Krzysztof Letachowicz, MD, PhD

  Wroclaw Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Krzysztof Letachowicz, MD, PhD

CONTACT

+48717332546; krzysztof.letachowicz@umed.wroc.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 21, 2020
• Study Start: January 3, 2020
• Primary Completion: January 2, 2022
• Study Completion: January 2, 2022
• Last Updated: July 21, 2020

Record last verified: 2020-06

Locations

PL (1)