OPTIMISE-CKD Study_Dapagliflozin Effectiveness in 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 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)

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease

• Study Type: Observational
• Enrollment (Actual): 12894

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28002
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The overall study population will consist of adult (aged > 18 years at index date) patients with CKD

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cohort of patients treated with Dapagliflozin 10 mg; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline demographics and clinical characteristics (comorbidities) of the study cohorts	Age (years old) Gender (female, N(%)) Comorbidities (N(%) Cardiovascular comorbidity (ICD code) Type 2 diabetes (ICD code) Hypertension (ICD code)	From 1-Aug-2021 to 31-Dec-2025
Baseline laboratory measures (number of measures per year and their values)		From 1-Aug-2021 to 31-Dec-2025
Concomitant medications, by drug class and specific drugs of interest (proportion of patients with prescription of selected drugs and prescriber characteristics for Dapagliflozin if available).		From 1-Aug-2021 to 31-Dec-2025
Compare selected outcomes	eGFR decline with time, (difference from baseline value)	From 1-Aug-2021 to 31-Dec-2025
Compare selected health-care resource utilization and cost	Compare selected health-care resource utilization and cost (resource consumption refers to that which is directly related to CKD): -initiation of dialysis -all-cause hospitalizations -heart failure hospitalizations (hHF) - CKD hospitalizations -primary care visits -hospital specialty visits -emergency visits	From 1-Aug-2021 to 31-Dec-2025

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2026
• Primary Completion (Actual): May 6, 2026
• Study Completion (Actual): May 6, 2026

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: D169AR00037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.