Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2682052 participants
OBSERVATIONAL
2022-05-04
2023-09-28
Brief Summary
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Detailed Description
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Primary objective: to characterize dapagliflozin 10mg utilisation in clinical practice, by describing treatment naïve patients who (1) are treated with dapagliflozin 10 mg and (2) who are eligible for CKD treatment with dapagliflozin but untreated.
Secondary objectives: to describe the current clinical landscape among incident CKD patients, by:
1. Describing baseline demographic and clinical characteristics, drug utilization, and CKD treatment (RAASi and dapagliflozin 10 mg) patterns; and
2. Describing selected outcomes among overall, treated and untreated incident CKD patients.
Exploratory objectives: to assess the real-world effectiveness of dapagliflozin in CKD patients, pending feasibility.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Dapagliflozin 10mg initiators
Adult patients (aged ≥18 years) with chronic kidney disease, who received a dapagliflozin 10mg prescription on or after the country-specific CKD indication approval date, and who did not previously have a prescription for dapagliflozin.
No interventions assigned to this group
Dapagliflozin 10mg eligible but untreated
Adult patients (aged ≥18 years) with chronic kidney disease, who meet the country-specific approved dapagliflozin 10mg treatment criteria for CKD on or after the local CKD indication approval date, but have not received a prescription
No interventions assigned to this group
Incident CKD
Adults patients (aged ≥18 years) who newly meet the CKD definition (diagnosis or laboratory indication) during the study period.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Chronic kidney disease (diagnosis code, uACR \>30mg/g or 2 eGFR ≥90 days apart, second value ≥75ml/min/1.73m2)
* ≥365 days continuous enrolment in database
Exclusion Criteria
* History of dapagliflozin 10mg prescriptions before index date
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Minneota, Minnesota, United States
Research Site
Kyoto, Kyoto, Japan
Research Site
Tokyo, , Japan
Research Site
Uppsala, , Sweden
Research Site
Uppsala, , Sweden
Countries
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Related Links
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Other Identifiers
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D169AR00015
Identifier Type: -
Identifier Source: org_study_id
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