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
Qualifiers
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 design
Treatments tested in this trial
- Not listed
Trial groups
60 Participants
are grouped into 3 trial groupsSponsors and collaborators
Source ClinicalTrials.gov