Replication of the DAPA-CKD (Chronic Kidney Disease) Trial in Healthcare Claims Data
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Brigham and Women's Hospital
- Study ID
- NCT04882813
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Dapagliflozin — DRUGDapagliflozin dispensing claim is used as the exposure group.
- Sitagliptin — DRUGSitagliptin dispensing claim is used as the reference group.
Study Details
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
Key Dates
- Start date
- Dec 13, 2020
- Status verified
- Jul 2023
- Primary completion
- Jun 11, 2021
- Completion
- Jun 11, 2021
Study Design
- Enrollment
- 87,727 participants (actual)
Arms
- Arm: DapagliflozinExposure group
- Arm: SitagliptinReference group
Primary Outcome Measure
Relative hazard of the composite of end-stage renal disease or all-cause mortality [ Time Frame: To study completion or censoring, up to 32 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02120 | - |
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