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Fibrosis, Inflammation, Oxygenation of Renal Tissue In FabrY Disease

NCT06325488 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-04-06

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Caroline Michaela Kistorp

    lead OTHER

Principal Investigators

  • Caroline M Kistorp, Professor · Rigshospitalet, Denmark

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2026-03-01
Completion
2026-06-01

Countries

  • Denmark

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06325488 on ClinicalTrials.gov