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Search / Trial NCT06325488

Fibrosis, Inflammation, Oxygenation of Renal Tissue In FabrY Disease

Launched by CAROLINE MICHAELA KISTORP · Mar 15, 2024

Trial Information

Current as of July 21, 2025

Recruiting

Keywords

Oxygenation Inflammation Fibrosis

ClinConnect Summary

This clinical trial is investigating how Fabry disease affects the kidneys, focusing specifically on changes in oxygen levels within kidney tissues. Researchers will use a special type of MRI that doesn't require any dyes or injections to look at kidney inflammation, injury, and scarring. They want to understand how these factors relate to the symptoms and signs of kidney problems in people with Fabry disease compared to healthy individuals of similar age and gender.

To participate, individuals must be at least 18 years old and able to give their consent. Those diagnosed with Fabry disease are eligible, but certain conditions, such as pregnancy or issues that would make an MRI unsafe (like having metal implants), may exclude them. Participants will have blood tests to investigate their kidney health and will undergo the MRI scan to assess their kidney function. This study aims to find better ways to understand and potentially treat kidney issues related to Fabry disease.

Gender

ALL

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

About Caroline Michaela Kistorp

Caroline Michaela Kistorp is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes. With a focus on innovative therapeutic solutions, she orchestrates clinical studies that adhere to the highest ethical standards and regulatory compliance. Leveraging her expertise in trial design and patient engagement, Caroline fosters collaborative relationships among stakeholders, including researchers, healthcare professionals, and participants. Her mission is to drive scientific discovery and enhance the understanding of treatment efficacy through rigorous clinical trials, ultimately contributing to the advancement of healthcare.

Locations

Copenhagen, , Denmark

Patients applied

0 patients applied

Trial Officials

Caroline M Kistorp, Professor

Principal Investigator

Rigshospitalet, Denmark

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported