OPTIMISE-CKD Study_current clinical landscape in Spain

Study identifier:D169AR00032

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Will Be Recruiting

Official Title

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

Medical condition

Renal disease

Phase

N/A

Healthy volunteers

Study drug

Sex

All

Estimated Enrollment

86516

Study type

Observational

Age

18 Years - n/a

Date

Study Start Date: 30 Sept 2024

Estimated Primary Completion Date: 28 Feb 2025

Estimated Study Completion Date: 28 Feb 2025

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -

Verification:

Verified 01 Sept 2024 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

No locations available

Arms	Assigned Interventions
Cohort 1 Pre-pricing & reimbursement, incident renal disease cohort (study observation period 2020- 2024)	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.
Cohort 2 Post-pricing & reimbursement, incident renal disease cohort (study observation period 2023-2024)	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

Arms

Assigned Interventions

Cohort 1
Pre-pricing & reimbursement, incident renal disease cohort (study observation period 2020- 2024)

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.

Cohort 2
Post-pricing & reimbursement, incident renal disease cohort (study observation period 2023-2024)

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

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]