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

Study Overview
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Brief Summary
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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
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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 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) 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 Assess trends in the prevalence (point prevalence) of undiagnosed CKD by calendar year Describe baseline characteristics among those with undiagnosed versus diagnosed CKD Assess CKD management and monitoring practices (post index date) in patients with diagnosed versus undiagnosed CKD Exploratory objectives (pending feasibility) Describe the risk of selected adverse clinical outcomes longitudinally among those with undiagnosed versus diagnosed CKD Describe HCRU associated with undiagnosed versus diagnosed CKD 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 Describe health care costs associated with undiagnosed versus diagnosed CKD 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): Estimate the point prevalence of undiagnosed CKD Describe the risk of selected adverse clinical outcomes longitudinally among those with undiagnosed CKD Describe HCRU and costs associated with undiagnosed CKD

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

Conditions
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Chronic Kidney Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least two consecutive eGFR laboratory tests with values ≥30 and <60 mL/min/1.73 m2 (Stage 3A or 3B) that are >90 and ≤730 days apart. The index date is the date of the second eGFR measure meeting the criteria for stage 3 CKD At least 12 months of continuous presence in the database or registration in the data prior to the first qualifying eGFR (for data sources with information on enrolment) Age ≥18 years at index date Exclusion Criteria: Solid organ transplant before the study index date Any evidence of advanced CKD (stage 4, 5) based on CKD diagnostic codes, or renal replacement therapy before the index date

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stage 3 chronic kidney disease patients<br>Patients with two consecutive eGFR measurements indicating stage 3 CKD (≥30 and <60 mL/min/1.73m2) during the observation period | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of undiagnosed stage 3 chronic kidney disease (CKD) | Undiagnosed stage 3A-3B CKD identified as having no healthcare encounter with a diagnosis code for CKD any time before or up to six months post index date (date of second consecutive estimated glomerular filtration rate [eGFR] value indicating stage 3 CKD recorded at least 90 days after the first abnormal eGFR value), assessed overall and by calendar year | From 2015 assessed throughout the study, up to a maximum of 8 years | 
| Time to CKD diagnosis | Time to CKD diagnosis in patients no CKD diagnosis code any time prior to laboratory measurements indicating stage 3 CKD | From second abnormal eGFR value until the date of CKD diagnosis or end of follow-up, assessed throughout the study period, up to a maximum of 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe proportion of patients comorbidities and other patient characteristics | Describe patient characteristics including demographics, clinical assessments, family history, procedures, laboratory measurements, treatment patterns and clinical history (comorbidities) stratified by CKD diagnosis status | From 2015 assessed throughout the study, up to a maximum of 8 years | 
| Proportion of patients monitored for kidney function and complications | Serum Cr test (outpatient) Patients receiving a UACR test (outpatient) Serum calcium Phosphate Albumin Bicarbonate Potassium Hemoglobin Albuminuria | From six months after the second abnormal eGFR measurement, assessed throughout the study period until end of follow-up, up to a maximum 18 months | 
| Proportion of patients tested for CKD | - UACR test | From six months after the second abnormal eGFR measurement, assessed throughout the study period until end of follow-up, up to a maximum 6 months | 
| Proportion of patients prescribed selected medications | Statin prescription Angiotensin converting enzyme inhibitors (ACEis) or angiotensin receptor blockers (ARBs) Sodium-glucose cotransporter-2 (SGLT2) inhibitors Vaccination (influenza) | From six months after the second abnormal eGFR measurement, assessed throughout the study period until the end of follow-up, up to a maximum 5 years | 
| Proportion of patients monitored for high blood pressure | Patients receiving BP measurement BP measurement ≤140/90 BP measurement ≤ 130/80 in patients with evidence of albuminuria and/or diabetes | From six months after the second abnormal eGFR measurement, assessed throughout the study period until end of follow-up, up to a maximum 5 years | 
| Proportion of patients monitored for glycaemic control | - HbA1c test in patients with diabetes | From six months after the second abnormal eGFR measurement, assessed throughout the study period until end of follow-up, up to a maximum 5 years | 
| Proportion of patients receiving kidney function monitoring after initiation of angiotensin receptor blocker or angiotensin converting enzyme inhibitors | - An outpatient serum creatinine measurement | From six months after the second abnormal eGFR measurement, assessed throughout the study period until end of follow-up, up to a maximum 5 years |