Study identifier:D169AR00015
ClinicalTrials.gov identifier:NCT05932901
EudraCT identifier:N/A
CTIS identifier:N/A
A multinational, observational, secondary data study describing management and treatment with dapagliflozin in routine clinical practice among patients with chronic kidney disease
Chronic Kidney Disease
N/A
No
-
All
2682052
Observational
18 Years - 130 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Apr 2024 by AstraZeneca
AstraZeneca
-
This is a multi-national, observational study program using secondary data sources to address research questions related to 1) real-world dapagliflozin utilisation in CKD and potential for further utilisation, 2), the current CKD treatment landscape and 3) real-world effectiveness of dapagliflozin in CKD (pending feasibility assessment).
OPTIMISE-CKD is an observational study program using secondary data sources to address research questions related to 1) real-world dapagliflozin utilisation in CKD and potential for further utilisation, 2), the current CKD treatment landscape and 3) real-world effectiveness of dapagliflozin in CKD (pending feasibility assessment). 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.
Location
Location
Kyoto City, Kyoto Prefecture, Japan, 604-0086
Location
Tokyo, Tokyo, Japan, 101-0053
Location
Minnesota, Minnesota, United States, 13625
Location
Uppsala, Sweden, 75322
Location
Uppsala, Sweden, 75320
Arms | Assigned Interventions |
---|---|
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. | - |
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 | - |
Incident CKD Adults patients (aged ≥18 years) who newly meet the CKD definition (diagnosis or laboratory indication) during the study period. | - |
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