OPTIMISE-CKD Drug Utilization

Completed

• Conditions: Chronic Kidney Disease

• Registration Number: NCT05932901
• Lead Sponsor: AstraZeneca

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2022-05-04
• Study First Submitted: 2023-05-05
• Study First Submitted QC: 2023-07-03
• Study First Posted: 2023-07-06
• Primary Completion: 2023-09-28
• Study Completion: 2023-09-28
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2682052

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Baseline comedications	1 year pre-index	Number and proportion of patients with comedications for cardiovascular disease, diabetes, hyperkalemia
Baseline sodium in mmol/L	1 year pre-index	Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum
Baseline demographics	1 year pre-index	Patient demographic characteristics including age, sex, race and insurance type (if data are available)
Baseline clinical characteristics	1 year pre-index	Number and proportion of patients with comorbidities, including heart failure, cardiovascular disease, type 2 diabetes, hypertension, hyperkalemia, myocardial infarction, stroke
Baseline eGFR in ml/min/1.73m2	1 year pre-index	Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum
Baseline uACR in mg/g	1 year pre-index	Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum
Baseline serum creatinine in mg/dl	1 year pre-index	Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum
Baseline calcium in mg/dl	1 year pre-index	Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum
Baseline hemoglobin A1c in %	1 year pre-index	Number and proportion of patients with available data Mean, standard deviation, median, interquartile range, minimum, maximum
Baseline hematocrit in %	1 year pre-index	Number and proportion of patients with available data Mean, standard deviation, median, interquartile range, minimum, maximum, % patients with value \<40
Baseline systolic blood pressure in mmHg	1 year pre-index	Number and proportion of patients with available data Mean, standard deviation, median, interquartile range, minimum, maximum

Secondary Outcome Measures

Name	Time	Method
Proportion of patients who initiate cardiorenal protective medication	1 year post-index	Treatment initiation (RASi and/or SGLT2i/dapagliflozin 10mg) following incident CKD index date
Proportion of patients with hospitalisations following incident CKD index	1 year post-index	Hospitalisations (any reason, CKD, heart failure) following incident CKD index
Average healthcare cost for specific outcomes/reasons	1 year post-index	Healthcare costs related to hospitalisation for CKD, heart failure, atherosclerotic CVD following incident CKD index
Proportion of patients who continue cardiorenal protective medication	1 year post-index	Treatment persistence (RASi and/or SGLT2i/dapagliflozin 10mg) following initiation after incident CKD index date

Trial Locations

Locations (1)

Research Site; 🇸🇪 Uppsala, Sweden