OPTIMISE-CKD Study_current Clinical Landscape in Spain

AstraZeneca

Status: Completed

Conditions: Renal Disease

Treatments: 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)

Study type: Observational

Funder types: Industry

Identifiers

NCT06614712

D169AR00032

Details and patient eligibility

About

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

Enrollment: 91,628 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

91,628 participants in 2 patient groups

Cohort 1

Description:

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

Treatment:

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

Cohort 2

Description:

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

Treatment:

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