Renal Disease
Conditions
Brief summary
OPTIMISE-CKD is a retrospective, observational study, using secondary data. The incidence of renal disease, including CKD, using eGFR or UACR laboratory measurements and diagnostic codes will be assessed in the study population. The study will also assess the incidence of selected cardiovascular and renal events and the current use of kidney-protective treatments
Interventions
OTHERPre-pricing & reimbursement, incident renal disease cohort (study observation period 2020- 2024)
Incident renal disease patients in this cohort are defined as those that newly met the renal function measurement definition stated above, with first-ever registered laboratory UACR and/or eGFR measurements or CKD diagnosis on or after the start date of this cohort study period, the 1st August 2020 and until the 1 st February 2023 (DAPA\_CKD P&R date in Spain). The first of the dates fulfilling any of the criteria defined above for the renal function measurement or CKD diagnosis, is defined as the patient index date-1 of this study cohort. At the index date-1, the renal disease will be staged based on eGFR (and/or UACR measurements in addition, if available) as specified in the KDIGO guidelines. Patients will be followed up from the index date-1 until the end of continuous enrolment, last date of available data or date of death, until the end of the overall observation period.
OTHERPost-pricing & reimbursement, incident renal disease cohort (study observation period 2023-2024)
We define the post-P&R cohort including all incident renal disease patients observed in the dapagliflozin-CKD post-pricing and reimbursement period. Patients in this cohort newly met the renal function measurement definition stated above, with first-ever registered laboratory UACR and/or eGFR measurements or CKD diagnosis on or after the 1 st February 2023 (DAPA\_CKD P&R date in Spain) and until the end of the study observation period. The first of the dates fulfilling any of the criteria defined above for the renal function measurement or CKD diagnosis, is defined as the patient index date-2 of this study cohort. At the index date-2, the renal disease will be staged based on eGFR (and/or UACR measurements in addition, if available) as specified in the KDIGO guidelines. Patients will be followed up from the index date-2 until the end of continuous enrolment, last date of available data or date of death, until the end of the overall study period
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age ≥18 years as of study index date * With renal function measured as either of the following: * At least 1 UACR measure of ≥30 mg/g; OR * At least 2 eGFR measures taken ≥90 days apart, of which both eGFR is ≤75 ml/min/1.73m2 ; OR * registered with Chronic Kidney Disease (CKD) diagnosis in the medical history (without biochemical confirmation)
Exclusion criteria
* History of stage 5 CKD, dialysis, organ transplant, type 1 diabetes, or gestational diabetes on or before the start date of the observation period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concomitant medications, by drug class and specific drugs of interest (proportion of patients with prescription of selected drugs) of the two cohorts of the study, pre-P&R and post-P&R cohorts, at their respective index dates. | Concomitant medications, by drug class and specific drugs of interest (proportion of patients with prescription of selected drugs) of the two cohorts of the study, pre-P&R and post-P&R cohorts, at their respective index dates. |
| Baseline demographics and clinical characteristics of the two cohorts of the study, pre-P&R and post-P&R cohorts, at their respective index dates. | from the 1st August 2020 to 30th September 2024 |
| Baseline laboratory measures (number of measures per year and their values) of the two cohorts of the study, pre-P&R and post-P&R cohorts, at their respective index dates. | from the 1st August 2020 to 30th September 2024 |
| Discontinuation of ongoing RAASi and/or SGLT-2i treatment among treated patients (proportion of patients, time to discontinuation) in the two cohorts of the study, pre-P&R and post-P&R cohorts. | from the 1st August 2020 to 30th September 2024 |
| Initiation of kidney-protective treatment (RAASi or SGLT2i or both) among treatment naïve patients in the pre-P&R cohort and post- P&R | from the 1st August 2020 to 30th September 2024 |
| Discontinuation of newly initiated RAASi or SGLT-2i treatment in the two cohorts of the study, pre-P&R and post-P&R cohorts | from the 1st August 2020 to 30th September 2024 |
Secondary
| Measure | Time frame |
|---|---|
| To describe the current clinical landscape among incident renal disease/incident CKD patients and in new initiators of kidney protective treatment- patients during the follow-up period | from the 1st August 2020 to 30th September 2024 |
Countries
Spain
Outcome results
None listed