RecruitingNCT07450820

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


Sponsor

AstraZeneca

Enrollment

14,308 participants

Start Date

Feb 18, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

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)


Eligibility

Min Age: 18 YearsMax Age: 130 Years

Inclusion Criteria4

  • 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.
  • months continuous enrolment in the data base prior to index
  • months continuous enrolment in the data base after index date.

Exclusion Criteria2

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

Locations(1)

Research Site

Madrid, Spain

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NCT07450820


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