Fibrosis, Inflammation, Oxygenation of Renal Tissue In FabrY Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCaroline Michaela Kistorp
About this trial
The overall objective of this study is to investigate Fabry-associated renal organ involvement by using a novel magnetic resonance imaging (MRI) approach, focusing on changes in renal oxygen levels by blood oxygenation-level dependent (BOLD) imaging. Furthermore, to correlate renal oxygenation to the phenotypic presentation of patients with Fabry-associated nephropathy regarding circulating and imaging-derived biomarkers of kidney inflammation, fibrosis and injury as compared with healthy age- and sex-matched controls.
The study will achieve this by:
1\) Using a non-invasive, contrast-free MRI protocol focusing on parameters of oxygenation, inflammation, fibrosis, and injury in the kidney.
2\) Using an extensive, in-depth biomarker blood panel to investigate the pathological pathways associated with Fabry disease and Fabry-associated nephropathy.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male and female individuals (≥18 years of age)
Able to give informed consent
Disqualifiers
Any contraindication for magnetic resonance imaging according to standard checklist used in clinical routine, including claustrophobia or metallic foreign bodies, metallic implants, internal electrical devices, or permanent makeup/tattoos that cannot be declared MR compatible.
Pregnancy
Male and female individuals (≥18 years of age)
Able to give informed consent Exclusion criteria
Trial population
Participants with Fabry disease (n=40) - previously established by genetic testing - are to be grouped according to the presence of renal impairment as defined by the KDIGO criteria. A group of controls with no renal impairment are to act as healthy controls.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 3 trial groupsGroup A: Patients with Fabry Disease and impaired kidney function
Group B: Patients with Fabry Disease and normal kidney function
Group C: Healthy controls
Trial outcomes
Primary outcomes
1
Renal hypoxia (Fabry patients according to renal impairment)
A between-group difference in renal hypoxia (R\*) evaluated by BOLD MRI when comparing the groups of patients with Fabry disease.
Time frame
At baselineSecondary outcomes
1
Renal hypoxia (Fabry patient vs controls)
A between-group difference in renal hypoxia (R\*) evaluated by BOLD MRI when comparing patients with Fabry disease irrespective of renal impairment with the control group.
Time frame
At baseline2
Renal cortical perfusion (Fabry vs. controls)
A between-group difference in perfusion of the renal medulla (mL/100g/min) when comparing groups with Fabry disease patients with the control group
Time frame
At baseline3
Renal medullar perfusion (Fabry vs. controls)
A between-group difference in renal blood flow (mL/min) when comparing groups with Fabry disease patients with the control group.
Time frame
At baseline4
Renal inflammation (Fabry vs. controls)
A between-group difference in native T1 (ms) when comparing groups with Fabry disease patients with the control group.
Time frame
At baselineSponsors and contacts
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Source ClinicalTrials.gov