OPTIMISE-CKD Study_Dapagliflozin Effectiveness in CKD

AstraZeneca

Status: Enrolling

Conditions: Chronic Kidney Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT07450820

D169AR00037

Details and patient eligibility

About

This is a retrospective, observational study, using secondary data captured in electronic health records (EHRs). The study is a part of the OPTIMISE-CKD program to assess the current CKD treatment landscape, Dapagliflozin utilisation and characterization of incident CKD patient and the burden of disease within an observation period of 39 months (August 2020-November 2024) in two cohorts (preand post-reimbursement of Dapagliflozin for CKD)

Enrollment: 14,308 estimated patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meets CKD definition criteria: having at least two eGFR measures ≤60 ml/min/1.73m2 measured ≥90 to 730 days apart and/or UACR ≥ 30 mg/g, and/or at least one measurement indicative of proteinuria (or with proteinuria ERA-ICD code) or CKD code.
• Age ≥18 years.
• 12 months continuous enrolment in the data base prior to index
• 12 months continuous enrolment in the data base after index date.

Exclusion criteria

• T1DM on or before index date.
• Diagnosis of gestational diabetes mellitus on or before index date

Trial design

14,308 participants in 2 patient groups

Cohort of patients treated with Dapagliflozin 10 mg

Description:

Cohort of patients treated with Dapagliflozin 10 mg. Patients who start treatment with Dapagliflozin after meeting the inclusion criteria. The first prescription of Dapagliflozin 10 mg will be considered as the index date.

Comparator cohort without specific treatment for CKD other than RASi

Description:

Patients who do not receive Dapagliflozin, but who meet the inclusion criteria and have RASi as CKD treatment or no specific treatment for CKD other than RASi. The index date will be matched with that of your Dapagliflozin-treated counterpart, within a ±10-day window.