Dapagliflozin use in chronic kidney disease (OPTIMISE-CKD)
A Multinational, Observational, Retrospective, Secondary Data Study Analyzing Dapagliflozin Effectiveness in Routine Clinical Practice Among Patients With Chronic Kidney Disease. Local Adaptation for Spain. Part 2
This retrospective study uses electronic health records to see how Dapagliflozin is being used and what the burden of chronic kidney disease looks like before and after reimbursement in adults with CKD.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 14308 (estimated) |
| Ages | 18 Years to 130 Years |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 1 site (Madrid) |
| Trial ID | NCT07450820 on ClinicalTrials.gov |
What this trial studies
OPTIMISE-CKD is a retrospective, observational analysis using secondary electronic health record data from August 2020 to November 2024 to characterize Dapagliflozin utilization and the burden of chronic kidney disease. The study compares two cohorts defined by pre- and post-reimbursement periods for Dapagliflozin across a 39-month observation window. Eligible adults must meet CKD laboratory or diagnostic-code criteria and have at least 12 months of continuous data before and after an index date, with exclusion of type 1 diabetes and gestational diabetes. Analyses focus on describing utilization patterns, incident CKD patient characteristics, and disease burden rather than testing clinical efficacy.
Who should consider this trial
Good fit: Adults aged 18 or older with CKD defined by repeated reduced eGFR or elevated proteinuria/UACR who have at least 12 months of continuous EHR enrollment before and after the index date and no type 1 or gestational diabetes.
Not a fit: Patients without the required continuous EHR data, those with type 1 diabetes or gestational diabetes, or those lacking necessary laboratory or diagnostic records are excluded and unlikely to benefit from this analysis.
Why it matters
Potential benefit: If successful, the findings could help clinicians and health systems understand real-world Dapagliflozin use and guide prescribing, reimbursement decisions, and resource planning for people with CKD.
How similar studies have performed: Randomized trials such as DAPA-CKD have shown clinical benefit of dapagliflozin in CKD and some observational work has characterized real-world use, but comprehensive pre/post-reimbursement EHR analyses are less common.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Madrid
- Research Site — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.