Clinical trial NCT05932901: OPTIMISE-CKD Drug Utilization
Official title: A Multinational, Observational, Secondary Data Study Describing Management and Treatment With Dapagliflozin in Routine Clinical Practice Among Patients With Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-07-06
Enrollment: 2682052
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The overall study population will consist of adult (aged \> 18 years) patients with CKD

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.

Eligibility criteria: 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

Primary outcomes:
measure: Baseline demographics
timeFrame: 1 year pre-index
measure: Baseline clinical characteristics
timeFrame: 1 year pre-index
measure: Baseline comedications
timeFrame: 1 year pre-index
measure: Baseline eGFR in ml/min/1.73m2
timeFrame: 1 year pre-index
measure: Baseline uACR in mg/g
timeFrame: 1 year pre-index
measure: Baseline serum creatinine in mg/dl
timeFrame: 1 year pre-index
measure: Baseline calcium in mg/dl
timeFrame: 1 year pre-index
measure: Baseline sodium in mmol/L
timeFrame: 1 year pre-index
measure: Baseline hemoglobin A1c in %
timeFrame: 1 year pre-index
measure: Baseline hematocrit in %
timeFrame: 1 year pre-index
measure: Baseline systolic blood pressure in mmHg
timeFrame: 1 year pre-index
Secondary outcomes:
measure: Proportion of patients who initiate cardiorenal protective medication
timeFrame: 1 year post-index
measure: Proportion of patients who continue cardiorenal protective medication
timeFrame: 1 year post-index
measure: Proportion of patients with hospitalisations following incident CKD index
timeFrame: 1 year post-index
measure: Average healthcare cost for specific outcomes/reasons
timeFrame: 1 year post-index
Other outcomes:
Locations:
city: Minnesota
country: United States
facility: Research Site
state: Minnesota
city: Kyoto City
country: Japan
facility: Research Site
state: Kyoto Prefecture
city: Tokyo
country: Japan
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
References: