OPTIMISE-CKD Study_current Clinical Landscape in Spain
Recruiting
- Conditions
- Renal Disease
- Interventions
- Other: Pre-pricing & reimbursement, incident renal disease cohort (study observation period 2020- 2024)Other: Post-pricing & reimbursement, incident renal disease cohort (study observation period 2023-2024)
- Registration Number
- NCT06614712
- Lead Sponsor
- AstraZeneca
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 86516
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 1 Pre-pricing & reimbursement, incident renal disease cohort (study observation period 2020- 2024) Pre-pricing \& reimbursement, incident renal disease cohort (study observation period 2020- 2024) Cohort 2 Post-pricing & reimbursement, incident renal disease cohort (study observation period 2023-2024) Post-pricing \& reimbursement, incident renal disease cohort (study observation period 2023-2024)
- Primary Outcome Measures
Name Time Method 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 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. 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 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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Research Site
🇪🇸Sevilla, Spain