Actively Recruiting
Fibrosis, Inflammation, Oxygenation of Renal Tissue In FabrY Disease
Led by Caroline Michaela Kistorp · Updated on 2025-04-06
60
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
C
Caroline Michaela Kistorp
Lead Sponsor
S
Sanofi
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Fibrosis, Inflammation, Oxygenation of Renal Tissue In FabrY Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female individuals 18 years of age or older
- Able to give informed consent
You will not qualify if you...
- Any contraindication for magnetic resonance imaging, including claustrophobia, metallic foreign bodies, metallic implants, internal electrical devices, or permanent makeup/tattoos not declared MR compatible
- Pregnancy
- For control group: genetically verified Fabry disease or family member with Fabry disease
- Cancer expected to influence life expectancy
- Known heart failure, previous stroke, or established kidney disease
- Initiation or change of antihypertensive therapy within 3 months before enrollment
- Renal impairment classified as CKD G2/A1 or worse
AI-Screening
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Trial Site Locations
Total: 1 location
1
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
Research Team
C
Caroline M Kistorp, Professor
CONTACT
N
Niels H Brandt-Jacobsen, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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