Assess Urine Biomarkers to Predict Nephropathy in Fabry Disease
NCT ID: NCT06065605
Last Updated: 2023-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2023-09-14
2025-09-12
Brief Summary
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Detailed Description
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There will be a total of 25 biomarkers that will be assessed during the study. Biomarkers of inflammation
1. Il-4
2. Il-6
3. IL-8
4. Il-10
5. Il-12
6. Il-18
7. MCP1
8. TGF-β1
9. IFN-γ
10. TNF-α
11. IL-1β
12. RANTES
13. BAFF
14. APRIL
15. PAI-1 Biomarkers of kidney function and proteinuria
16. B2M
17. Bikunin
18. NGAL
19. Osteopontin
20. Clusterin
21. Creatinine Acute kidney injury
22. KIM-1
23. YKL-40
24. EGF
25. CK-18 M30
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Fabry patients without clinical evidence of nephropathy
No deterioration of kidney function.
No interventions assigned to this group
Fabry patients with clinical evidence of nephropathy
Deterioration of kidney function.
No interventions assigned to this group
Naïve Fabry patients
These patients have no received treatment.
No interventions assigned to this group
Healthy controls
Not diagnosed with Fabry disease.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Subject willing to sign the informed consent and/or assent.
* Confirmed diagnosis of Fabry disease based on deficient α-Gal A enzymatic activity and molecular analysis demonstrating pathogenic variants in the GLA gene.
Exclusion Criteria
* Evidence of hepatitis B or C infections or other chronic infectious diseases,
* Pregnancy or breastfeeding.
* Any other chronic condition, as per PI's discretion, that makes the subject ineligible.
18 Years
80 Years
ALL
Yes
Sponsors
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Lysosomal and Rare Disorders Research and Treatment Center, Inc.
OTHER
Responsible Party
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Locations
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Lysosomal & Rare Disorders Research & Treatment Center
Rockville, Maryland, United States
Lysosomal & Rare Disorders Research & Treatment Center
Fairfax, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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23-LDRTC-01
Identifier Type: -
Identifier Source: org_study_id
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