Status:
WITHDRAWN
Post-Authorisation Safety Study of Lesinurad
Lead Sponsor:
AstraZeneca
Conditions:
Gout
Hyperuricemia
Eligibility:
All Genders
18+ years
Brief Summary
Non-interventional population-based prospective cohort study in multiple databases comparing patients with gout who initiate lesinurad in combination with an existing xanthine oxidase inhibitor (XOI) ...
Eligibility Criteria
Inclusion
- More than one dispensing/prescription for an xanthine oxidase inhibotor (XOI) within the past 183 days prior to the index date and days' supply extending beyond the index date
- A coded diagnosis of gout at any time in the past or on the index date
- Age 18 years or older
- Continuous enrolment in the database for the past 183 days
Exclusion
- Patients on urate-lowering therapy medications within 6 months prior to the index date to manage gout (probenecid, benzbromarone, or pegloticase) other than an XOI (allopurinol, febuxostat) or lesinurad (not including medications to treat gout flares).
- Patients with severe renal impairment defined using clinical diagnostic codes (i.e., a diagnosis code of CKD stage IV, end-stage renal disease, or an indicator that eCrCl is \< 30 mL/min at any time prior to the index date).
Key Trial Info
Start Date :
January 29 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04072471
Start Date
January 29 2021
End Date
June 30 2023
Last Update
April 19 2021
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