OPTIMISE-CKD Drug Utilization

Study Overview
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Brief Summary
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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
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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: Describing baseline demographic and clinical characteristics, drug utilization, and CKD treatment (RAASi and dapagliflozin 10 mg) patterns; and 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.

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

Conditions
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Chronic Kidney Disease

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 130 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dapagliflozin 10mg initiators<br>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. | |
| Dapagliflozin 10mg eligible but untreated<br>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 | |
| Incident CKD<br>Adults patients (aged ≥18 years) who newly meet the CKD definition (diagnosis or laboratory indication) during the study period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline demographics | Patient demographic characteristics including age, sex, race and insurance type (if data are available) | 1 year pre-index | 
| 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 | 
| Baseline comedications | Number and proportion of patients with comedications for cardiovascular disease, diabetes, hyperkalemia | 1 year pre-index | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Baseline hemoglobin A1c in % | Number and proportion of patients with available data Mean, standard deviation, median, interquartile range, minimum, maximum | 1 year pre-index | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Proportion of patients with hospitalisations following incident CKD index | Hospitalisations (any reason, CKD, heart failure) following incident CKD index | 1 year post-index | 
| 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 |