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Completed

NCT Number: NCT07450820

OPTIMISE-CKD Study_Dapagliflozin Effectiveness in CKD

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)

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Madrid, 28002, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Baseline demographics and clinical characteristics (comorbidities) of the study cohorts

    Time frame: From 1-Aug-2021 to 31-Dec-2025

    Age (years old) Gender (female, N(%)) Comorbidities (N(%) Cardiovascular comorbidity (ICD code) Type 2 diabetes (ICD code) Hypertension (ICD code)

  2. Baseline laboratory measures (number of measures per year and their values)

    Time frame: From 1-Aug-2021 to 31-Dec-2025

  3. 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).

    Time frame: From 1-Aug-2021 to 31-Dec-2025

  4. Compare selected outcomes

    Time frame: From 1-Aug-2021 to 31-Dec-2025

    eGFR decline with time, (difference from baseline value)

  5. Compare selected health-care resource utilization and cost

    Time frame: From 1-Aug-2021 to 31-Dec-2025

    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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 5, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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