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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort of patients treated with Dapagliflozin 10 mg | Cohort of patients treated with Dapagliflozin 10 mg. Patients who start treatment with Dapagliflozin after meeting the inclusion criteria. The first prescription of Dapagliflozin 10 mg will be considered as the index date. | ||
| Comparator cohort without specific treatment for CKD other than RASi | Patients who do not receive Dapagliflozin, but who meet the inclusion criteria and have RASi as CKD treatment or no specific treatment for CKD other than RASi. The index date will be matched with that of your Dapagliflozin-treated counterpart, within a ±10-day window. |
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| Measure | Description | Time Frame |
|---|---|---|
| Baseline demographics and clinical characteristics (comorbidities) of the study cohorts | Age (years old) Gender (female, N(%)) Comorbidities (N(%) Cardiovascular comorbidity (ICD code) Type 2 diabetes (ICD code) Hypertension (ICD code) | From 1-Aug-2021 to 31-Dec-2025 |
| 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 | eGFR decline with time, (difference from baseline value) | From 1-Aug-2021 to 31-Dec-2025 |
| Compare selected health-care resource utilization and cost | 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 | From 1-Aug-2021 to 31-Dec-2025 |
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Inclusion Criteria:
Exclusion Criteria:
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The overall study population will consist of adult (aged > 18 years at index date) patients with CKD
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Madrid | 28002 | Spain |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |