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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)
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
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
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
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
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
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
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
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
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
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


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