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A Multinational, Observational, Secondary Data Study Describing Management and Treatment With Dapagliflozin in Routine Clinical Practice Among Patients With Chronic Kidney Disease
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.
Age
18 - 130 years
Sex
ALL
Healthy Volunteers
No
Research Site
Minneota, Minnesota, United States
Research Site
Kyoto, Kyoto, Japan
Research Site
Tokyo, Japan
Research Site
Uppsala, Sweden
Research Site
Uppsala, Sweden
Start Date
May 4, 2022
Primary Completion Date
September 28, 2023
Completion Date
September 28, 2023
Last Updated
April 17, 2024
2,682,052
ACTUAL participants
Lead Sponsor
AstraZeneca
NCT07241390
NCT06926660
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06717698