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

Chronic Kidney Disease Clinical Trial

— REVEAL-CKD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04847531
• Other study ID #: D169AR00003
• Status: Completed
• Start date: December 15, 2020
• Est. completion date: November 13, 2023

Study information

• Verified date: April 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1006361
• Est. completion date: November 13, 2023
• Est. primary completion date: November 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Australia	Research Site	Sydney	New South Wales
Brazil	Research Site	Sao Paulo
Canada	Research Site	Kingston	Ontario
China	Research Site	Guangzhou	Guangdong
France	Research Site	Boulogne-Billancourt
Germany	Research Site	Frankfurt
Italy	Research Site	Milan
Japan	Research Site	Kyoto
Spain	Research Site	Madrid
United Kingdom	Research Site	London	Greater London
United States	Research Site	Ann Arbor	Michigan
United States	Research Site	Cambridge	Massachusetts
United States	Research Site	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  China,  France,  Germany,  Italy,  Japan,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of adverse renal events	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)	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
Other	Incidence of all-cause mortality	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
Other	CKD progression	Progression to CKD stage 4 or higher	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
Other	Incidence of Cardiovascular (CV) events	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	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
Other	Describe health care resource utilisation and associated costs	To understand the healthcare resource use and cost associated with undiagnosed CKD	From six months after the second abnormal eGFR, assessed throughout the study until end of follow-up, up to a maximum of 5 years
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   The CSR synopsis_D169AR00003