Kidney TransplantationAVARTNCT04478968
Approach to Vascular Access After Renal Transplantation
An observational study of Kidney Transplantation, run by Wroclaw Medical University at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- presence of AVF
- How many people
- 150 participants
- Where
- 1 sitePoland
- Study dates
- 3 Jan 2020to 2 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have had a kidney transplant belong to the group of patients at increased risk for cardiovascular disease.
Who may be able to join
- age> 18 years old
- kidney transplant
- >12 months after transplantation
- stable transplanted kidney function
- signed informed consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Nephrology and Transplantation Medicine
Wroclaw, 55-556
Krzysztof Letachowicz, MD, PhD, +48717332546, krzysztof.letachowiocz@umed.wroc.pl
About this study
Official title: The Levels of Fibrosis Biomarkers in Patients After Renal Transplantation in Relation to Arteriovenous Fistula Function
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.
Read the 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
- Being tested
- presence of AVF
- Keywords
- Arteriovenous Fistula
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
presence of AVFOther
Functioning AVF may have cardiotoxic potential
| Study group | Role | What they receive |
|---|---|---|
| Active AVF | Patients after kidney transplantation with functioning AVF Receives: Other: presence of AVF | |
| No AVF | Patients after kidney transplantation without AVF (thrombosed AVF, history of HD with catheter, history of PD, preemptive transplantation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline visit and up to 12 months
Secondary outcomes (1)
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.
Measured: Up to 12 months from baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start3 Jan 2020
- Primary completion2 Jan 2022 (estimated)
- Study completion2 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Krzysztof Letachowicz, MD, PhD, Principal investigator, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478968
- Sponsor's protocol ID
- MINI.C160.20.001
- Acronym
- AVART
- Status last verified
- Jun 2020
- First submitted
- 29 Jun 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Krolicka A, Kuriata-Kordek M, Iwanicki M, Banasik M, Letachowicz K. Limitations of Fried frailty criteria in kidney transplant recipients with arteriovenous fistulas. J Vasc Access. 2026 Sep 26:11297298261485658. doi: 10.1177/11297298261485658. Online ahead of print.
PubMed 42799344
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Levels of Fibrosis Biomarkers in Patients After Renal Transplantation in Relation to Arteriovenous Fistula Function
- ClinicalTrials.gov ID
- NCT04478968
- Acronym / sponsor ID
- AVART / MINI.C160.20.001
- Conditions
- Kidney Transplantation
- Keywords
- Arteriovenous Fistula
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 2 Jan 2022 (estimated)
- Study completion
- 2 Jan 2022 (estimated)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active AVF | – | Other: presence of AVFPatients after kidney transplantation with functioning AVF |
| No AVF | – | –Patients after kidney transplantation without AVF (thrombosed AVF, history of HD with catheter, history of PD, preemptive transplantation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have had a kidney transplant belong to the group of patients at increased risk for cardiovascular disease.
Key inclusion criteria (5 listed)
- age> 18 years old
- kidney transplant
- >12 months after transplantation
- stable transplanted kidney function
- signed informed consent
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| presence of AVFFunctioning AVF may have cardiotoxic potential | Other | Active AVF |
Primary outcome
Quality of life with EQ-5D-5L
Time frame: Baseline visit up to 12 months
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.
Prognostic value of biomarkers (NT-proBNP, Il-6, sST2, galectin-3, GDF-15, MMP7, TIMP1)
Time frame: Baseline visit and up to 12 months
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.
1 secondary outcome
Hospitalization-free survival
Time frame: Up to 12 months from baseline visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Derived from this study: PubMed 42799344Krolicka A, Kuriata-Kordek M, Iwanicki M, Banasik M, Letachowicz K. Limitations of Fried frailty criteria in kidney transplant recipients with arteriovenous fistulas. J Vasc Access. 2026 Sep 26:11297298261485658. doi: 10.1177/11297298261485658. Online ahead of print.
- Individual participant dataSharing planned: Undecided
Related trials for Kidney Transplantation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krzysztof Letachowicz, MD, PhD principal investigator
Wroclaw Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation, run by Wroclaw Medical University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Krzysztof Letachowicz, MD, PhD (+48717332546, krzysztof.letachowicz@umed.wroc.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life with EQ-5D-5L (time frame: Baseline visit up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04478968, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.