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NCT Number: NCT05015231

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

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

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Key information

Conditions

Kidney Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Zurich

Zurich, 8091, Switzerland

Location status: Recruiting

Location contact

Thomas Müller, Professor

CONTACT

0041 (0)44 255 11 11

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echocardiography and MRI

Diagnostic Test

Echocardiography and renal MRI before and after fistula closure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas Müller, Professor

CONTACT

thomas.mü[email protected]

0041 (0)44 255 11 11

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Acronym: FISCLO

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Aug 20, 2021
Registry last updated
Aug 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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