NCT06614712

OPTIMISE-CKD Study_current Clinical Landscape in Spain

A Multinational, Observational, Retrospective, Secondary Data Study Describing Management and Treatment in Routine Clinical Practice Among Patients With Chronic Kidney Disease. Local Adaptation for Spain. Part 1

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 91,628 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Renal Disease

Interventions

Type	Name	Description
OTHER	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.
OTHER	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

Timeline

• Start date: 2024-12-04
• Primary completion: 2025-10-06
• Completion: 2025-10-06
• First posted: 2024-09-26
• Last updated: 2025-10-10

Locations

1 site across 1 country: Spain