Status: Planned First registered on: 05/07/2019
Last updated on: 05/07/2019
1. Study identification
EU PAS Register NumberEUPAS30385
Official titleAn Observational Post-Authorisation Safety Study of Lesinurad Patients
Study title acronymSATURATES
Study typeObservational study
Brief description of the studyNon-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) (lesinurad+XOI cohort) to a propensity score-matched cohort of similar patients from the same data source who continue treatment with XOI monotherapy (XOI mono cohort). Study will characterize the cardiovascular safety of lesinurad in combination with XOI in patients with gout aged 18+ years compared with similar patients who continue XOI monotherapy. Primary objective: to assess the relative incidence of major adverse cardiac events plus hospitalization for unstable angina (MACE+ events) in patients with gout in both cohorts. Secondary objectives: to describe the characteristics of the cohorts prior to matching; to assess the relative incidence of hospitalisation for acute kidney injury between the matched cohorts; to assess the relative incidence of individual MACE+ components in the matched cohorts.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 1 (imposed as condition of marketing authorisation)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableD5310R00016
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsRTI-HS
Department/Research groupEpidemiology
Organisation/affiliationRTI Health Solutions
Website/Homepagehttps://www.rtihs.org/
Details of (Primary) lead investigator
Title Dr
Last name Rivero
First name Elena
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?4

HealthCore, United States
Countries in which this study is being conducted
International study

Italy
Spain
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed15/03/201630/03/2016
Start date of data collection30/09/2021
Start date of data analysis30/11/2021
Date of interim report, if expected
Date of final study report30/09/2024
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstra Zeneca100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Rivero
First name Elena
Address line 11800 Concord Pike
Address line 2PO Box 15437 
Address line 3 
CityWilmington, De 
Postcode19850 
CountryUnited States
Phone number (incl. country code)0018772409479 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Dr 
Last name AstraZeneca 
First name Clinical Study Information Center 
Address line 11800 Concord Pike 
Address line 2PO Box 15437 
Address line 3 
CityWilmington, De 
Postcode 
CountryUnited States 
Phone number (incl. country code)0018772409479 
Alternative phone number 
Fax number (incl. country code) 
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