Research Site
Seville, 41092, Spain
NCT Number: NCT06614712
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
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Notify Me18 year and older
All sexes
Observational
Seville, 41092, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Age ≥18 years as of study index date
Exclusion criteria
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.
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
Time frame: from the 1st August 2020 to 30th September 2024
Time frame: from the 1st August 2020 to 30th September 2024
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.
Time frame: from the 1st August 2020 to 30th September 2024
Time frame: from the 1st August 2020 to 30th September 2024
Time frame: from the 1st August 2020 to 30th September 2024
Time frame: from the 1st August 2020 to 30th September 2024
AstraZeneca
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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