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 — DRUG
    Dapagliflozin dispensing claim is used as the exposure group.
  • Sitagliptin — DRUG
    Sitagliptin 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: Dapagliflozin
    Exposure group
  • Arm: Sitagliptin
    Reference 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)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02120-

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