REVEAL-CKD: Prevalence and Consequences of Undiagnosed Chronic Kidney Disease
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
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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)
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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
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Assess trends in the prevalence (point prevalence) of undiagnosed CKD by calendar year
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Describe baseline characteristics among those with undiagnosed versus diagnosed CKD
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Assess CKD management and monitoring practices (post index date) in patients with diagnosed versus undiagnosed CKD
Exploratory objectives (pending feasibility)
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Describe the risk of selected adverse clinical outcomes longitudinally among those with undiagnosed versus diagnosed CKD
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Describe HCRU associated with undiagnosed versus diagnosed CKD
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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
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Describe health care costs associated with undiagnosed versus diagnosed CKD
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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):
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Estimate the point prevalence of undiagnosed CKD
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Describe the risk of selected adverse clinical outcomes longitudinally among those with undiagnosed CKD
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Describe HCRU and costs associated with undiagnosed CKD
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Stage 3 chronic kidney disease patients Patients with two consecutive eGFR measurements indicating stage 3 CKD (≥30 and <60 mL/min/1.73m2) during the observation period |
Outcome Measures
Primary Outcome Measures
- Prevalence of undiagnosed stage 3 chronic kidney disease (CKD) [From 2015 assessed throughout the study, up to a maximum of 8 years]
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
- Time to CKD diagnosis [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]
Time to CKD diagnosis in patients no CKD diagnosis code any time prior to laboratory measurements indicating stage 3 CKD
Secondary Outcome Measures
- Describe proportion of patients comorbidities and other patient characteristics [From 2015 assessed throughout the study, up to a maximum of 8 years]
Describe patient characteristics including demographics, clinical assessments, family history, procedures, laboratory measurements, treatment patterns and clinical history (comorbidities) stratified by CKD diagnosis status
- Proportion of patients monitored for kidney function and complications [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]
Serum Cr test (outpatient) Patients receiving a UACR test (outpatient) Serum calcium Phosphate Albumin Bicarbonate Potassium Hemoglobin Albuminuria
- Proportion of patients tested for CKD [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]
- UACR test
- Proportion of patients prescribed selected medications [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]
Statin prescription Angiotensin converting enzyme inhibitors (ACEis) or angiotensin receptor blockers (ARBs) Sodium-glucose cotransporter-2 (SGLT2) inhibitors Vaccination (influenza)
- Proportion of patients monitored for high blood pressure [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]
Patients receiving BP measurement BP measurement ≤140/90 BP measurement ≤ 130/80 in patients with evidence of albuminuria and/or diabetes
- Proportion of patients monitored for glycaemic control [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]
- HbA1c test in patients with diabetes
- Proportion of patients receiving kidney function monitoring after initiation of angiotensin receptor blocker or angiotensin converting enzyme inhibitors [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]
- An outpatient serum creatinine measurement
Other Outcome Measures
- Incidence of adverse renal events [From six months after the second abnormal eGFR until the date of an adverse renal outcome, assessed throughout the study until end of follow-up, up to a maximum of 5 years]
Sustained ≥50% reduction in eGFR; or End stage kidney disease (ESKD); defined as a composite of chronic dialysis, renal transplant, or sustained eGFR<15mL/min/1.732 (at least two consecutive measures ≥28 days apart)
- Incidence of all-cause mortality [From six months after the second abnormal eGFR until death due to any cause, assessed throughout the study until end of follow-up, up to a maximum of 5 years]
All-cause mortality
- CKD progression [From six months after the second abnormal eGFR until the date of CKD progression, assessed throughout the study until end of follow-up, up to a maximum of 5 years]
Progression to CKD stage 4 or higher
- Incidence of Cardiovascular (CV) events [From six months after the second abnormal eGFR until the date of a CV event, assessed throughout the study until end of follow-up, up to a maximum of 5 years]
Composite of non-fatal MI, non-fatal stroke, or CV death Composite of non-fatal MI, non-fatal stroke, or all-cause mortality) Composite of non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or CV death Stroke Hospitalisation for heart failure
- Describe health care resource utilisation and associated costs [From six months after the second abnormal eGFR, assessed throughout the study until end of follow-up, up to a maximum of 5 years]
To understand the healthcare resource use and cost associated with undiagnosed CKD
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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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)
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Age ≥18 years at index date
Exclusion Criteria:
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Solid organ transplant before the study index date
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Any evidence of advanced CKD (stage 4, 5) based on CKD diagnostic codes, or renal replacement therapy before the index date
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Louisville | Kentucky | United States | 40202 |
| 2 | Research Site | Cambridge | Massachusetts | United States | 02140 |
| 3 | Research Site | Ann Arbor | Michigan | United States | 48108 |
| 4 | Research Site | Sydney | New South Wales | Australia | 2040 |
| 5 | Research Site | Boulogne-Billancourt | France | 92641 | |
| 6 | Research Site | Frankfurt | Germany | 60549 | |
| 7 | Research Site | Milan | Italy | 20124 | |
| 8 | Research Site | Kyoto | Japan | 604-0086 | |
| 9 | Research Site | Madrid | Spain | 28037 | |
| 10 | Research Site | London | Greater London | United Kingdom | E14 4PU |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Principal Investigator: Navdeep Tangri, University of Manitoba
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D169AR00003