Chronic Kidney Disease
Conditions
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.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 130 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 comedications | 1 year pre-index | Number and proportion of patients with comedications for cardiovascular disease, diabetes, hyperkalemia |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 initiate cardiorenal protective medication | 1 year post-index | Treatment initiation (RASi and/or SGLT2i/dapagliflozin 10mg) following incident CKD index date |
Countries
Japan, Sweden, United States
Outcome results
None listed