NCT06325488 Fibrosis, Inflammation, Oxygenation of Renal Tissue In FabrY Disease
| NCT ID | NCT06325488 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Caroline Michaela Kistorp |
| Condition | Fabry Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2024-06-01 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Fabry patients: 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
Contact & Investigator
Caroline M Kistorp, Professor
PRINCIPAL INVESTIGATOR
Rigshospitalet, Denmark
Frequently Asked Questions
Who can join the NCT06325488 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fabry Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06325488 currently recruiting?
Yes, NCT06325488 is actively recruiting participants. Contact the research team at caroline.michaela.kistorp@regionh.dk for enrollment information.
Where is the NCT06325488 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT06325488 clinical trial?
NCT06325488 is sponsored by Caroline Michaela Kistorp. The principal investigator is Caroline M Kistorp, Professor at Rigshospitalet, Denmark. The trial plans to enroll 60 participants.