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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04847531




Registration number
NCT04847531
Ethics application status
Date submitted
29/03/2021
Date registered
19/04/2021

Titles & IDs
Public title
REVEAL-CKD: Prevalence and Consequences of Undiagnosed Chronic Kidney Disease
Scientific title
REVEAL-CKD: A Retrospective, Multinational Observational Study to Determine the Prevalence and Consequences of Undiagnosed Chronic Kidney Disease
Secondary ID [1] 0 0
D169AR00003
Universal Trial Number (UTN)
Trial acronym
REVEAL-CKD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Prevalence of undiagnosed stage 3 chronic kidney disease (CKD)
Assessment method [1] 0 0
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
Timepoint [1] 0 0
From 2015 assessed throughout the study, up to a maximum of 8 years
Primary outcome [2] 0 0
Time to CKD diagnosis
Assessment method [2] 0 0
Time to CKD diagnosis in patients no CKD diagnosis code any time prior to laboratory measurements indicating stage 3 CKD
Timepoint [2] 0 0
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 [1] 0 0
Describe proportion of patients comorbidities and other patient characteristics
Assessment method [1] 0 0
Describe patient characteristics including demographics, clinical assessments, family history, procedures, laboratory measurements, treatment patterns and clinical history (comorbidities) stratified by CKD diagnosis status
Timepoint [1] 0 0
From 2015 assessed throughout the study, up to a maximum of 8 years
Secondary outcome [2] 0 0
Proportion of patients monitored for kidney function and complications
Assessment method [2] 0 0
* Serum Cr test (outpatient) * Patients receiving a UACR test (outpatient) * Serum calcium * Phosphate * Albumin * Bicarbonate * Potassium * Hemoglobin * Albuminuria
Timepoint [2] 0 0
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 outcome [3] 0 0
Proportion of patients tested for CKD
Assessment method [3] 0 0
- UACR test
Timepoint [3] 0 0
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 outcome [4] 0 0
Proportion of patients prescribed selected medications
Assessment method [4] 0 0
* Statin prescription * Angiotensin converting enzyme inhibitors (ACEis) or angiotensin receptor blockers (ARBs) * Sodium-glucose cotransporter-2 (SGLT2) inhibitors * Vaccination (influenza)
Timepoint [4] 0 0
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 outcome [5] 0 0
Proportion of patients monitored for high blood pressure
Assessment method [5] 0 0
* Patients receiving BP measurement * BP measurement =140/90 * BP measurement = 130/80 in patients with evidence of albuminuria and/or diabetes
Timepoint [5] 0 0
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 outcome [6] 0 0
Proportion of patients monitored for glycaemic control
Assessment method [6] 0 0
- HbA1c test in patients with diabetes
Timepoint [6] 0 0
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 outcome [7] 0 0
Proportion of patients receiving kidney function monitoring after initiation of angiotensin receptor blocker or angiotensin converting enzyme inhibitors
Assessment method [7] 0 0
- An outpatient serum creatinine measurement
Timepoint [7] 0 0
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

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/11/2023
Sample size
Target
Accrual to date
Final
1006361
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Research Site - Sydney
Recruitment postcode(s) [1] 0 0
2040 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Kentucky
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
Brazil
State/province [4] 0 0
Sao Paulo
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
China
State/province [6] 0 0
Guangdong
Country [7] 0 0
France
State/province [7] 0 0
Boulogne-Billancourt
Country [8] 0 0
Germany
State/province [8] 0 0
Frankfurt
Country [9] 0 0
Italy
State/province [9] 0 0
Milan
Country [10] 0 0
Japan
State/province [10] 0 0
Kyoto
Country [11] 0 0
Spain
State/province [11] 0 0
Madrid
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Greater London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Navdeep Tangri
Address 0 0
University of Manitoba
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04847531