NCT05932901

OPTIMISE-CKD Drug Utilization

A Multinational, Observational, Secondary Data Study Describing Management and Treatment With Dapagliflozin in Routine Clinical Practice Among Patients With Chronic Kidney Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,682,052 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Chronic Kidney Disease

Timeline

• Start date: 2022-05-04
• Primary completion: 2023-09-28
• Completion: 2023-09-28
• First posted: 2023-07-06
• Last updated: 2024-04-17

Locations

5 sites across 3 countries: United States, Japan, Sweden