OPTIMISE-CKD Study_current Clinical Landscape in Spain

Last updated: April 8, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

N/A

Condition

Nephropathy

Renal Failure

Kidney Disease

Treatment

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

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

Clinical Study ID

NCT06614712
D169AR00032
  • Ages > 18
  • All Genders

Study 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

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 ≤75ml/min/1.73m2 ; OR

  • registered with Chronic Kidney Disease (CKD) diagnosis in the medical history (without biochemical confirmation)

Exclusion

Exclusion Criteria:

  • History of stage 5 CKD, dialysis, organ transplant, type 1 diabetes, or gestationaldiabetes on or before the start date of the observation period

Study Design

Total Participants: 86516
Treatment Group(s): 2
Primary Treatment: Post-pricing & reimbursement, incident renal disease cohort (study observation period 2023-2024)
Phase:
Study Start date:
December 04, 2024
Estimated Completion Date:
May 15, 2025

Connect with a study center

  • Research Site

    Sevilla, 41092
    Spain

    Active - Recruiting

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