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NCT05015231 Clinical Trial

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

Kidney Transplantation Clinical Trial

— FISCLO  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05015231
Other study ID # 2021-00474
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2021
Est. completion date December 31, 2027

Study information
Verified date August 2021
Source University of Zurich
Contact Thomas Müller, Professor
Phone 0041 (0)44 255 11 11
Email thomas.müller@usz.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date December 31, 2027
Est. primary completion date December 31, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Echocardiography and MRI
Echocardiography and renal MRI before and after fistula closure

Locations
Country Name City State
Switzerland University Hospital Zurich Zurich

Sponsors (1)
Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of changes in renal hemodynamics by multiparametric MRI after closure of AVF access Assessing changes in renal perfusion evaluation of short term changes within 2 weeks after fistula closure and longterm changes 6 months after fistula closure
Primary Assessment of changes in renal hemodynamics by multiparametric MRI after closure of AVF access 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 Correlation between AVF access flow and changes as assessed during pneumatic fistula compression with changes in renal hemodynamics 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
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