OPTIMISE-CKD Drug Utilization

NCT ID: NCT05932901

Last Updated: 2024-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2682052 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-04

Study Completion Date

2023-09-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a multi-national, observational study program using secondary data sources to address research questions related to 1) real-world dapagliflozin utilisation in CKD and potential for further utilisation, 2), the current CKD treatment landscape and 3) real-world effectiveness of dapagliflozin in CKD (pending feasibility assessment).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

OPTIMISE-CKD is an observational study program using secondary data sources to address research questions related to 1) real-world dapagliflozin utilisation in CKD and potential for further utilisation, 2), the current CKD treatment landscape and 3) real-world effectiveness of dapagliflozin in CKD (pending feasibility assessment).

Primary objective: to characterize dapagliflozin 10mg utilisation in clinical practice, by describing treatment naïve patients who (1) are treated with dapagliflozin 10 mg and (2) who are eligible for CKD treatment with dapagliflozin but untreated.

Secondary objectives: to describe the current clinical landscape among incident CKD patients, by:

1. Describing baseline demographic and clinical characteristics, drug utilization, and CKD treatment (RAASi and dapagliflozin 10 mg) patterns; and
2. Describing selected outcomes among overall, treated and untreated incident CKD patients.

Exploratory objectives: to assess the real-world effectiveness of dapagliflozin in CKD patients, pending feasibility.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Kidney Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dapagliflozin 10mg initiators

Adult patients (aged ≥18 years) with chronic kidney disease, who received a dapagliflozin 10mg prescription on or after the country-specific CKD indication approval date, and who did not previously have a prescription for dapagliflozin.

No interventions assigned to this group

Dapagliflozin 10mg eligible but untreated

Adult patients (aged ≥18 years) with chronic kidney disease, who meet the country-specific approved dapagliflozin 10mg treatment criteria for CKD on or after the local CKD indication approval date, but have not received a prescription

No interventions assigned to this group

Incident CKD

Adults patients (aged ≥18 years) who newly meet the CKD definition (diagnosis or laboratory indication) during the study period.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult patients (aged ≥18 years)
* Chronic kidney disease (diagnosis code, uACR \>30mg/g or 2 eGFR ≥90 days apart, second value ≥75ml/min/1.73m2)
* ≥365 days continuous enrolment in database

Exclusion Criteria

* History of type 1 diabetes, gestational diabetes or dialysis
* History of dapagliflozin 10mg prescriptions before index date
Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Minneota, Minnesota, United States

Site Status

Research Site

Kyoto, Kyoto, Japan

Site Status

Research Site

Tokyo, , Japan

Site Status

Research Site

Uppsala, , Sweden

Site Status

Research Site

Uppsala, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Japan Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D169AR00015

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Renal Mechanism of Action/Splay vs. TmG
NCT00726505 TERMINATED PHASE1
A Phase 2b Diabetic Kidney Disease Study
NCT04170543 COMPLETED PHASE2