Chronic Kidney Disease
Conditions
Brief summary
This is a retrospective, observational study, using secondary data captured in electronic health records (EHRs). The study is a part of the OPTIMISE-CKD program to assess the current CKD treatment landscape, Dapagliflozin utilisation and characterization of incident CKD patient and the burden of disease within an observation period of 39 months (August 2020-November 2024) in two cohorts (preand post-reimbursement of Dapagliflozin for CKD)
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
* Meets CKD definition criteria: having at least two eGFR measures ≤60 ml/min/1.73m2 measured ≥90 to 730 days apart and/or UACR ≥ 30 mg/g, and/or at least one measurement indicative of proteinuria (or with proteinuria ERA-ICD code) or CKD code. * Age ≥18 years. * 12 months continuous enrolment in the data base prior to index * 12 months continuous enrolment in the data base after index date.
Exclusion criteria
* T1DM on or before index date. * Diagnosis of gestational diabetes mellitus on or before index date
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline demographics and clinical characteristics (comorbidities) of the study cohorts | From 1-Aug-2021 to 31-Dec-2025 | Age (years old) Gender (female, N(%)) Comorbidities (N(%) Cardiovascular comorbidity (ICD code) Type 2 diabetes (ICD code) Hypertension (ICD code) |
| Baseline laboratory measures (number of measures per year and their values) | From 1-Aug-2021 to 31-Dec-2025 | — |
| Concomitant medications, by drug class and specific drugs of interest (proportion of patients with prescription of selected drugs and prescriber characteristics for Dapagliflozin if available). | From 1-Aug-2021 to 31-Dec-2025 | — |
| Compare selected outcomes | From 1-Aug-2021 to 31-Dec-2025 | eGFR decline with time, (difference from baseline value) |
| Compare selected health-care resource utilization and cost | From 1-Aug-2021 to 31-Dec-2025 | Compare selected health-care resource utilization and cost (resource consumption refers to that which is directly related to CKD): -initiation of dialysis -all-cause hospitalizations -heart failure hospitalizations (hHF) - CKD hospitalizations -primary care visits -hospital specialty visits -emergency visits |
Countries
Spain
Outcome results
None listed