OPTIMISE-CKD Drug Utilization

AstraZeneca

Status: Completed

Conditions: Chronic Kidney Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT05932901

D169AR00015

Details and patient eligibility

About

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).

Full 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.

Enrollment: 2,682,052 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (aged ≥18 years)
• Chronic kidney disease (diagnosis code, uACR >30mg/g or 2 eGFR ≥90 days apart, second value ≥75ml/min/1.73m2)
• ≥365 days continuous enrolment in database

Exclusion criteria

• History of type 1 diabetes, gestational diabetes or dialysis
• History of dapagliflozin 10mg prescriptions before index date

Trial design

2,682,052 participants in 3 patient groups

Dapagliflozin 10mg initiators

Description:

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

Description:

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

Description:

Adults patients (aged ≥18 years) who newly meet the CKD definition (diagnosis or laboratory indication) during the study period.