NCT04847531

REVEAL-CKD: Prevalence and Consequences of Undiagnosed Chronic Kidney Disease

REVEAL-CKD: A Retrospective, Multinational Observational Study to Determine the Prevalence and Consequences of Undiagnosed Chronic Kidney Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,006,361 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a retrospective, multinational, non-interventional, observational study. A series of cohort studies will be conducted to assess the prevalence of undiagnosed stage 3 CKD in each region. The study will also assess the current state of CKD management in patients with undiagnosed CKD

Detailed description

This study is a retrospective, multinational, non-interventional observational study. The study does not attempt to test any specific a priori hypothesis; it is descriptive only and will collect data under conditions of routine medical care. Relevant secondary databases will be identified, and a series of cohort studies will be conducted to assess the prevalence of undiagnosed CKD. The study will also assess the current state of CKD management in patients with undiagnosed CKD. Primary Objectives 1. Estimate the point prevalence of undiagnosed stage 3 CKD (proportion of patients with eGFR measurements indicating stage 3 CKD with no corresponding CKD diagnostic code either before or up to six months after the second abnormal eGFR value) 2. Describe time to CKD diagnosis in patients with no prior CKD diagnosis code at index date (time of second qualifying eGFR), overall and by patient characteristics Secondary Objectives 1. Assess trends in the prevalence (point prevalence) of undiagnosed CKD by calendar year 2. Describe baseline characteristics among those with undiagnosed versus diagnosed CKD 3. Assess CKD management and monitoring practices (post index date) in patients with diagnosed versus undiagnosed CKD Exploratory objectives (pending feasibility) 1. Describe the risk of selected adverse clinical outcomes longitudinally among those with undiagnosed versus diagnosed CKD 2. Describe HCRU associated with undiagnosed versus diagnosed CKD 3. Assess association between the timing of the CKD diagnosis and the risk of selected adverse clinical outcomes and HCRU in patients with no CKD diagnosis code prior to the index date 4. Describe health care costs associated with undiagnosed versus diagnosed CKD 5. For CKD patients with eGFR 25-75 mL/min/1.73m2 and urine albumin creatinine ratio (UACR) 200 - 5000 mg/g (DAPA-CKD trial-like population): 1. Estimate the point prevalence of undiagnosed CKD 2. Describe the risk of selected adverse clinical outcomes longitudinally among those with undiagnosed CKD 3. Describe HCRU and costs associated with undiagnosed CKD

Conditions

• Chronic Kidney Disease

Timeline

• Start date: 2020-12-15
• Primary completion: 2023-11-13
• Completion: 2023-11-13
• First posted: 2021-04-19
• Last updated: 2024-12-16

Locations

13 sites across 11 countries: United States, Australia, Brazil, Canada, China, France, Germany, Italy, Japan, Spain, United Kingdom