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

Sponsor
University of Zurich (Other)
Overall Status
Recruiting
CT.gov ID
NCT05015231
Collaborator
(none)
30
Enrollment
1
Location
77
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Echocardiography and MRI

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Multiparametric MRI for Assessment of Changes of Renal Hemodynamics After Fistula Closure in Kidney Transplant Patients: a Pilot Study
Actual Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2027
Anticipated Study Completion Date :
Dec 31, 2027

Outcome Measures

Primary Outcome Measures

  1. Assessment of changes in renal hemodynamics by multiparametric MRI after closure of AVF access [evaluation of short term changes within 2 weeks after fistula closure and longterm changes 6 months after fistula closure]

    Assessing changes in renal perfusion

  2. Assessment of changes in renal hemodynamics by multiparametric MRI after closure of AVF access [evaluation of short term changes within 2 weeks after fistula closure and longterm changes 6 months after fistula closure]

    Assessing changes in renal oxygenation

Secondary Outcome Measures

  1. 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]

    Correlation between AVF access flow and changes as assessed during pneumatic fistula compression with changes in renal hemodynamics after fistula closure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Zurich Zurich Switzerland 8091

Sponsors and Collaborators

  • University of Zurich

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Zurich
ClinicalTrials.gov Identifier:
NCT05015231
Other Study ID Numbers:
  • 2021-00474
First Posted:
Aug 20, 2021
Last Update Posted:
Aug 20, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Fistula

Study Results

No Results Posted as of Aug 20, 2021