Kidney TransplantationFISCLONCT05015231
Multiparametric MRI for Assessment of Changes of Renal Hemodynamics After Fistula Closure in Kidney Transplant Patients
An observational study of Kidney Transplantation, run by University of Zurich at 1 site in Switzerland.
Trial summary
Assessment of changes of renal hemodynamics by multiparametric MRI after closure of AVF 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?
- Echocardiography and MRI
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2021to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Kidney transplant recipients with a functioning graft and a patent hemodialysis fistula
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, 8091
Thomas Müller, Professor, 0041 (0)44 255 11 11
About this study
Official title: 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.
- Conditions
- Kidney Transplantation
- Being tested
- Echocardiography and MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiography and MRIDiagnostic test
Echocardiography and renal MRI before and after fistula closure
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of changes in renal hemodynamics by multiparametric MRI after closure of AVF access
Assessing changes in renal perfusion
Measured: 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
Assessing changes in renal oxygenation
Measured: evaluation of short term changes within 2 weeks after fistula closure and longterm changes 6 months after fistula closure
Secondary outcomes (1)
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
Measured: evaluation of short term changes within 2 weeks after fistula closure and longterm changes 6 months after fistula closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start1 Aug 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Müller, Professor, Principal investigator, University Hospital Zurich, Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015231
- Sponsor's protocol ID
- 2021-00474
- Acronym
- FISCLO
- Status last verified
- Aug 2021
- First submitted
- 9 Aug 2021
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric MRI for Assessment of Changes of Renal Hemodynamics After Fistula Closure in Kidney Transplant Patients: a Pilot Study
- ClinicalTrials.gov ID
- NCT05015231
- Acronym / sponsor ID
- FISCLO / 2021-00474
- Conditions
- Kidney Transplantation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Aug 2021 (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.
Assessment of changes of renal hemodynamics by multiparametric MRI after closure of AVF access.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney transplant recipients with a functioning graft and a patent hemodialysis fistula
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Echocardiography and MRIEchocardiography and renal MRI before and after fistula closure | Diagnostic test | – |
Primary outcome
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
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Thomas Müller, Professor principal investigator
University Hospital Zurich, Nephrology
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 University of Zurich at 1 site in Switzerland.
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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 20 Aug 2021. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Müller, Professor (0041 (0)44 255 11 11, thomas.müller@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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?
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 20 Aug 2021.