91,628
Participants
Start Date
December 4, 2024
Primary Completion Date
October 6, 2025
Study Completion Date
October 6, 2025
Pre-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."
Post-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
Research Site, Seville
Lead Sponsor
AstraZeneca
INDUSTRY