Fibrosis, Inflammation, Oxygenation of Renal Tissue In FabrY Disease
Recruiting · NCT06325488 · Observational (researchers observe without assigning treatment) · Lead sponsor: Caroline Michaela Kistorp
View the official record on ClinicalTrials.gov →What this trial is about
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 take part
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
Where it is running
1 location listed.
- Rigshospitalet - Copenhagen, Denmark