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Fibrosis, Inflammation, Oxygenation of Renal Tissue In FabrY Disease

Recruitingn/aAges 18 Years - anyAllCaroline Michaela Kistorp
NCT06325488 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Fabry patients: Inclusion Criteria: * Male and female individuals (≥18 years of age) * Able to give informed consent Exclusion Criteria: * 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 Control group Inclusion criteria * Male and female individuals (≥18 years of age) * Able to give informed consent Exclusion criteria * A genetically-verified diagnosis of Fabry disease. * Family member to a patient with a genetically-verified diagnosis of Fabry disease * Cancer expected to influence life expectancy. * Known heart failure, previous apoplexia or previously established kidney disease. * Initiation or change of antihypertensive therapy within 3 months of enrolment * Renal impairment as depicted by the CKD-EPI classification (≥ CKD G2/A1) * Any contraindication for MRI 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
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What it tests

  • Not listed
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Where

1 site
Rigshospitalet
Copenhagen, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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