NCT07450820

Brief 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)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14,308

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Feb 2026Feb 2027

First Submitted

Initial submission to the registry

February 4, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

February 18, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2027

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

February 4, 2026

Last Update Submit

April 24, 2026

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Madrid, 28002, Spain

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479information.center@astrazeneca.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2026

First Posted

March 5, 2026

Study Start

February 18, 2026

Primary Completion (Estimated)

February 9, 2027

Study Completion (Estimated)

February 9, 2027

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations

ES(1)