OPTIMISE-CKD Drug Utilization

Chronic Kidney Disease Clinical Trial

— OPTIMISE-CKD  

Official title:

A Multinational, Observational, Secondary Data Study Describing Management and Treatment With Dapagliflozin in Routine Clinical Practice Among Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05932901
• Other study ID #: D169AR00015
• Status: Completed
• Start date: May 4, 2022
• Est. completion date: September 28, 2023

Study information

• Verified date: April 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2682052
• Est. completion date: September 28, 2023
• Est. primary completion date: September 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Japan	Research Site	Kyoto City	Kyoto Prefecture
Japan	Research Site	Tokyo
Sweden	Research Site	Uppsala
Sweden	Research Site	Uppsala
United States	Research Site	Minnesota	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Japan,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline demographics	Patient demographic characteristics including age, sex, race and insurance type (if data are available)	1 year pre-index
Primary	Baseline clinical characteristics	Number and proportion of patients with comorbidities, including heart failure, cardiovascular disease, type 2 diabetes, hypertension, hyperkalemia, myocardial infarction, stroke	1 year pre-index
Primary	Baseline comedications	Number and proportion of patients with comedications for cardiovascular disease, diabetes, hyperkalemia	1 year pre-index
Primary	Baseline eGFR in ml/min/1.73m2	Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum	1 year pre-index
Primary	Baseline uACR in mg/g	Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum	1 year pre-index
Primary	Baseline serum creatinine in mg/dl	Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum	1 year pre-index
Primary	Baseline calcium in mg/dl	Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum	1 year pre-index
Primary	Baseline sodium in mmol/L	Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum	1 year pre-index
Primary	Baseline hemoglobin A1c in %	Number and proportion of patients with available data Mean, standard deviation, median, interquartile range, minimum, maximum	1 year pre-index
Primary	Baseline hematocrit in %	Number and proportion of patients with available data Mean, standard deviation, median, interquartile range, minimum, maximum, % patients with value <40	1 year pre-index
Primary	Baseline systolic blood pressure in mmHg	Number and proportion of patients with available data Mean, standard deviation, median, interquartile range, minimum, maximum	1 year pre-index
Secondary	Proportion of patients who initiate cardiorenal protective medication	Treatment initiation (RASi and/or SGLT2i/dapagliflozin 10mg) following incident CKD index date	1 year post-index
Secondary	Proportion of patients who continue cardiorenal protective medication	Treatment persistence (RASi and/or SGLT2i/dapagliflozin 10mg) following initiation after incident CKD index date	1 year post-index
Secondary	Proportion of patients with hospitalisations following incident CKD index	Hospitalisations (any reason, CKD, heart failure) following incident CKD index	1 year post-index
Secondary	Average healthcare cost for specific outcomes/reasons	Healthcare costs related to hospitalisation for CKD, heart failure, atherosclerotic CVD following incident CKD index	1 year post-index

External Links

•   redacted CSR Synopsis