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Screening test for Fabry disease in patients receiving haemodialysis in England

Screening for Fabry disease in the haemodialysis population

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN44751506
Enrollment
2200
Registered
2021-05-26
Start date
2022-08-04
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fabry disease Nutritional, Metabolic, Endocrine Other sphingolipidosis

Interventions

All eligible patients are given a patient information sheet (PIS) and consent form by the research nurse during one of their haemodialysis sessions. All potential participants will be given the opport

Sponsors

University Hospitals Birmingham NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 110 Years

Inclusion criteria

Inclusion criteria: 1. Patients receiving haemodialysis under the care of the six participating renal units 2. Aged 18 years and above 3. Capable of giving informed consent

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

MeasureTime frame
Prevalence of Fabry disease as defined by dried blood spot alfa-galactosidase A (GLA) enzyme activity, Lyso-Gb3 level and genetic mutation of GLA analysis at a single timepoint

Secondary

MeasureTime frame
1. Clinical characteristics of new cases of Fabry disease identified by the study, including age, gender, ethnicity, duration of dialysis, cardiovascular history, previous renal diagnosis and previous renal biopsy report, measured using review of medical records at the time of study recruitment 2. Fabry disease symptoms measured using a questionnaire designed by the SoFAH study which consists of six questions at the time of study recruitment (single timepoint) 3. Quality of life measured using EQ5D-5L at the time of study recruitment (single timepoint)

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 27, 2026