Clinical trial NCT06614712: OPTIMISE-CKD Study_current Clinical Landscape in Spain
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Renal Disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-09-26
Enrollment: 86516
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The overall study population will consist of adult patients, aged ≥18 years as of study index date, with their renal function measured

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


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: from the 1st August 2020 to 30th September 2024
measure: 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.
timeFrame: from the 1st August 2020 to 30th September 2024
measure: 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.
timeFrame: 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.
measure: Initiation of kidney-protective treatment (RAASi or SGLT2i or both) among treatment naïve patients in the pre-P&R cohort and post- P&R
timeFrame: from the 1st August 2020 to 30th September 2024
measure: Discontinuation of newly initiated RAASi or SGLT-2i treatment in the two cohorts of the study, pre-P&R and post-P&R cohorts
timeFrame: from the 1st August 2020 to 30th September 2024
measure: 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.
timeFrame: from the 1st August 2020 to 30th September 2024
Secondary outcomes:
measure: 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
timeFrame: from the 1st August 2020 to 30th September 2024
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Research Site
Study officials:
References: