RecruitingNot Applicable

Fibrosis, Inflammation, Oxygenation of Renal Tissue In FabrY Disease

Denmark60 participantsStarted 2024-06-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Renal hypoxia (Fabry patients according to renal impairment)

Timeframe: At baseline

Trial details

NCT IDNCT06325488

SponsorCaroline Michaela Kistorp

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-03-01

Contact for this trial

Caroline M Kistorp, Professor

35 45 96 42 caroline.michaela.kistorp@regionh.dk