Uses MRI to study kidney oxygen and damage in Fabry disease
Studies kidney oxygen and damage with scans in adults with Fabry disease.
Plain-language title generated from the registry record
Registry title: Fibrosis, Inflammation, Oxygenation of Renal Tissue In FabrY Disease
Key facts
- Where
- Copenhagen, DenmarkSee the site
Where in Denmark
- RigshospitaletCopenhagen, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Caroline Michaela Kistorp
- Trial code
- NCT06325488
- Record updated
- 6 April 2025
- Original description
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.Read full original descriptionShow less
Fibrosis, Inflammation, Oxygenation of Renal Tissue In FabrY Disease
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.
Inclusion: Male and female individuals (≥18 years of age); Able to give informed consent.
Exclusion: 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; Known heart failure, previous apoplexia or previously established kidney disease; Initiation or change of antihypertensive therapy within 3 months of enrolment; 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; 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; Renal impairment as depicted by the CKD-EPI classification (≥ CKD G2/A1); Male and female individuals (≥18 years of age); Pregnancy; Control group Inclusion criteria; Able to give informed consent Exclusion criteria; Pregnancy.
Fabry patients:.