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GoutSATURATESNCT04072471

Post-Authorisation Safety Study of Lesinurad

An observational study of Gout and Hyperuricemia, run by AstraZeneca.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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) (lesinurad+XOI cohort) to a propensity score-matched cohort of similar patients from the same data source who continue… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gout, Hyperuricemia
What is being tested?
Zurampic®
How many people
0 participants
Where
No sites listed yet
Study dates
29 Jan 2021to 30 Jun 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients in this study will be 18 years of age or older, will have had at least 6 months (183 days) of continuous baseline data available before entering one of the cohorts, and will be current users of XOI monotherapy (i.e., > 1 dispensing/prescription of a study XOI in the 183-day baseline period prior to the index date and days' supply extending beyond the index date). The study population will include patients from one primary care database in Italy (Health Search) and another in Spain (Information System for Research in Primary Care [SIDIAP]), as well as two US health systems (the HealthCore Integrated Research DatabaseSM [HIRD] and Medicare).

Who may be able to join

  • 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

Who cannot join

  • 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).

About this study

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) (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.

Conditions
Gout, Hyperuricemia
Being tested
Zurampic®, Control group: xanthine oxidase inhibitor monotherapy
Medical subject headings
Gout, Hyperuricemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zurampic®Drug

    Also called ATC code: M04A B05, Product name*: Zurampic®, Substance (INN)*: lesinurad

    non-interventional study where patients are exposed to Zurampic® plus a xanthine oxidase inhibitor (allopurinol or febuxostat) during the normal course of clinical practice

  • Control group: xanthine oxidase inhibitor monotherapyDrug

    non-interventional study where patients are exposed to xanthine oxidase inhibitor monotherapy (allopurinol or febuxostat) during the normal course of clinical practice

Study groups in NCT04072471
Study groupRoleWhat they receive
Zurampic®Patients exposed to Zurampic® plus a xanthine oxidase inhibitor (allopurinol or febuxostat) (lesinurad+XOI)
Receives: Drug: Zurampic®
Control group: xanthine oxidase inhibitor monotherapyPatients exposed to xanthine oxidase inhibitor monotherapy (allopurinol or febuxostat).
Receives: Drug: Control group: xanthine oxidase inhibitor monotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major Adverse Cardiac Events (MACE+)

    MACE+ is a composite endpoint comprised of: hospitalisation for non-fatal AMI, stroke, or unstable angina and cardiovascular (CV) death. CV death includes the following causes, occurring in or out of the hospital: AMI, sudden cardiac, heart failure, CV procedures, CV haemorrhage, stroke, underlying cerebrovascular cause, other CV causes.

    Measured: 2 year follow-up

Secondary outcomes (2)

  1. Hospitalisation for acute kidney injury (AKI) including renal failure (with AKI as the primary diagnosis)

    Confirmed cases of AKI require all three of the following criteria:

    • A diagnosis of renal injury or acute renal injury recorded as a primary hospital discharge diagnosis in the electronic database AND
    • An increase in serum creatinine at hospital admission or within 48 hours of hospital admission defined as follows:
    • Increase in serum creatinine by ≥ 1.5-fold from baseline where baseline is lowest value recorded within 1 year before the hospital admission date OR
    • Decrease in estimated glomerular filtration rate (eGFR) or actual 24-hour GFR by ≥ 50% from baseline where baseline is highest value recorded within 1 year before the hospital admission date OR
    • Estimated creatinine clearance (eCrCl) < 30 mL/min AND
    • Absence of all the following contraindications for lesinurad patients at any time prior to the index date:
    • A diagnosis code of chronic kidney disease stage IV or greater
    • eCrCl < 30 mL/min recorded at any time prior to the index date

    Measured: 2 year follow-up

  2. Each individual component of MACE+

    This can be the hospitalisation for non-fatal AMI, stroke, or unstable angina and cardiovascular (CV) death.

    Measured: 2 year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2019
  2. Study start29 Jan 2021 (estimated)
  3. Primary completion30 Jun 2023 (estimated)
  4. Study completion30 Jun 2023 (estimated)

Why it stopped: The study was withdrawn as lesinurad was withdrawn from the market in Europe by the market authorization holder. Hence the commitment to do this PASS was removed by the European Medicines Agency.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04072471
Sponsor's protocol ID
D5310R00016
Other IDs
EUPAS30385
Acronym
SATURATES
Status last verified
Mar 2021
First submitted
12 Aug 2019
Last updated
19 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Gout and Hyperuricemia, run by AstraZeneca.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Adverse Cardiac Events (MACE+) (time frame: 2 year follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04072471.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.

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