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NCT06325488: FORTIFY
Fibrosis, Inflammation, Oxygenation of Renal Tissue In FabrY Disease
trial in Fabry Disease in 60 participants. Currently enrolling.
1 March 2026
Quick facts
| Lead sponsor | Caroline Michaela Kistorp |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 60 |
| Start date | 1 June 2024 |
| Primary completion | 1 March 2026 |
| Estimated completion | 1 June 2026 |
| Sites | 1 location across Denmark |
Conditions studied
- Fabry Disease — all drugs for Fabry Disease →
- Chronic Kidney Diseases — all drugs for Chronic Kidney Diseases →
Sponsor
Caroline Michaela Kistorp
Who can join
18 and older, any sex, with Fabry Disease or Chronic Kidney Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06325488
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Fabry Disease
Currently open trials in the same condition.
- NCT07187440 — A Study of Agalsidase Alfa Enyzme Replacement Therapy in Chinese Children and Adults With Fabry Disease · recruiting
- NCT06776419 — the Role of cArdiac Inflammation, endoThelial Dysfunction, and FIbrosis in fabrY Disease · recruiting
- NCT06539624 — Evaluate the Safety and Preliminary Efficacy of EXG110 in Subjects With Fabry Disease · NA · recruiting
- NCT07277361 — Study of the Quality of Life of Patients With Fabry Disease Aged 65 and Over With and Without Specific Treatment · recruiting
- NCT06270316 — Safety, PK/PD, and Exploratory Efficacy Study of AMT-191 in Classic Fabry Disease · Phase 1, PHASE2 · recruiting
Other Caroline Michaela Kistorp trials
Trials by the same sponsor.
- NCT06776419 — the Role of cArdiac Inflammation, endoThelial Dysfunction, and FIbrosis in fabrY Disease · recruiting
- NCT06303466 — Real World Evidence Study of Danish Fabry Patients · unknown
- NCT05599438 — Prospective, Longitudinal Study on FItness DOping in DenmarK · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06325488 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Caroline Michaela Kistorp
- Last refreshed: 6 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06325488.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing