Multiparametric MRI for Assessment of Changes of Renal Hemodynamics After Fistula Closure in Kidney Transplant Patients (FISCLO)

August 17, 2021 updated by: University of Zurich

Multiparametric MRI for Assessment of Changes of Renal Hemodynamics After Fistula Closure in Kidney Transplant Patients: a Pilot Study

Assessment of changes of renal hemodynamics by multiparametric MRI after closure of AVF access.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • Recruiting
        • University Hospital Zürich
        • Contact:
          • Thomas Müller, Professor
          • Phone Number: 0041 (0)44 255 11 11

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Kidney transplant recipients with a functioning graft and a patent hemodialysis fistula

Description

Inclusion Criteria:

  • Written informed consent
  • Age > 18 years
  • Patients wishing to close the fistula and planned for surgical fistula closure
  • eGFR CKD EPI ≥ 45 ml/min/1.73m2 at one year post transplantation
  • Stable eGFR within the past 6 months
  • Controlled blood pressure

Exclusion Criteria:

  • Kidney Transplantation < 12 months before fistula closure
  • Proteinuria > 500mg/d
  • Presence of donor specific antibodies
  • Rejection within the past 6 months
  • BK virus replication within the past 3 months
  • Cardiac pacemaker, which is not compatible with MRI
  • Claustrophobia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of changes in renal hemodynamics by multiparametric MRI after closure of AVF access
Time Frame: evaluation of short term changes within 2 weeks after fistula closure and longterm changes 6 months after fistula closure
Assessing changes in renal perfusion
evaluation of short term changes within 2 weeks after fistula closure and longterm changes 6 months after fistula closure
Assessment of changes in renal hemodynamics by multiparametric MRI after closure of AVF access
Time Frame: evaluation of short term changes within 2 weeks after fistula closure and longterm changes 6 months after fistula closure
Assessing changes in renal oxygenation
evaluation of short term changes within 2 weeks after fistula closure and longterm changes 6 months after fistula closure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between AVF access flow and changes as assessed during pneumatic fistula compression with changes in renal hemodynamics after fistula closure
Time Frame: evaluation of short term changes within 2 weeks after fistula closure and longterm changes 6 months after fistula closure
Correlation between AVF access flow and changes as assessed during pneumatic fistula compression with changes in renal hemodynamics after fistula closure
evaluation of short term changes within 2 weeks after fistula closure and longterm changes 6 months after fistula closure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Thomas Müller, Professor, University Hospital Zurich, Nephrology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Anticipated)

December 31, 2027

Study Completion (Anticipated)

December 31, 2027

Study Registration Dates

First Submitted

August 9, 2021

First Submitted That Met QC Criteria

August 17, 2021

First Posted (Actual)

August 20, 2021

Study Record Updates

Last Update Posted (Actual)

August 20, 2021

Last Update Submitted That Met QC Criteria

August 17, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-00474

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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