Chronic Kidney DiseaseREVEAL-CKDNCT04847531
REVEAL-CKD: Prevalence and Consequences of Undiagnosed Chronic Kidney Disease
An observational study of Chronic Kidney Disease, run by AstraZeneca at 13 sites in 11 countries.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 1,006,361 participants
- Where
- 13 sitesin 11 countries
- Study dates
- 15 Dec 2020to 13 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients ≥18 years old with two consecutive eGFR measurements indicating stage 3 CKD (≥30 and <60 mL/min/1.73m2 using CKD-EPI (preferred) or MDRD equation) recorded more than 90 days apart (max. 730 days), meeting the inclusion criteria will be included in the study (from 2015 onwards).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
13 sites in 11 countries.
13 sites in 11 countries
United States3 sites
Research Site
Ann Arbor, Michigan, 48108
Research Site
Cambridge, Massachusetts, 02140
Research Site
Louisville, Kentucky, 40202
About this study
Official title: REVEAL-CKD: A Retrospective, Multinational Observational Study to Determine the Prevalence and Consequences of Undiagnosed Chronic Kidney Disease
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
Read the 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
- 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
- Conditions
- Chronic Kidney Disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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 outcomes (7)
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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start15 Dec 2020
- Primary completion13 Nov 2023
- Study completion13 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,006,361 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Navdeep Tangri, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847531
- Sponsor's protocol ID
- D169AR00003
- Acronym
- REVEAL-CKD
- Status last verified
- Dec 2024
- First submitted
- 29 Mar 2021
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Tangri N, Moriyama T, Schneider MP, Virgitti JB, De Nicola L, Arnold M, Barone S, Peach E, Wittbrodt E, Chen H, Jarbrink K, Kushner P. Prevalence of undiagnosed stage 3 chronic kidney disease in France, Germany, Italy, Japan and the USA: results from the multinational observational REVEAL-CKD study. BMJ Open. 2023 May 22;13(5):e067386. doi: 10.1136/bmjopen-2022-067386.
PubMed 37217263Tangri N, Peach EJ, Franzen S, Barone S, Kushner PR. Patient Management and Clinical Outcomes Associated with a Recorded Diagnosis of Stage 3 Chronic Kidney Disease: The REVEAL-CKD Study. Adv Ther. 2023 Jun;40(6):2869-2885. doi: 10.1007/s12325-023-02482-5. Epub 2023 May 3.
PubMed 37133647
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REVEAL-CKD: A Retrospective, Multinational Observational Study to Determine the Prevalence and Consequences of Undiagnosed Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04847531
- Acronym / sponsor ID
- REVEAL-CKD / D169AR00003
- Conditions
- Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,006,361 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 13 Nov 2023 (actual)
- Study completion
- 13 Nov 2023 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ≥18 years old with two consecutive eGFR measurements indicating stage 3 CKD (≥30 and <60 mL/min/1.73m2 using CKD-EPI (preferred) or MDRD equation) recorded more than 90 days apart (max. 730 days), meeting the inclusion criteria will be included in the study (from 2015 onwards).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of undiagnosed stage 3 chronic kidney disease (CKD)
Time frame: 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
Time frame: 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
7 secondary outcomes
Describe proportion of patients comorbidities and other patient characteristics
Time frame: From 2015 assessed throughout the study, up to a maximum of 8 years
Proportion of patients monitored for kidney function and complications
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Derived from this study: PubMed 37217263Tangri N, Moriyama T, Schneider MP, Virgitti JB, De Nicola L, Arnold M, Barone S, Peach E, Wittbrodt E, Chen H, Jarbrink K, Kushner P. Prevalence of undiagnosed stage 3 chronic kidney disease in France, Germany, Italy, Japan and the USA: results from the multinational observational REVEAL-CKD study. BMJ Open. 2023 May 22;13(5):e067386. doi: 10.1136/bmjopen-2022-067386.
- Derived from this study: PubMed 37133647Tangri N, Peach EJ, Franzen S, Barone S, Kushner PR. Patient Management and Clinical Outcomes Associated with a Recorded Diagnosis of Stage 3 Chronic Kidney Disease: The REVEAL-CKD Study. Adv Ther. 2023 Jun;40(6):2869-2885. doi: 10.1007/s12325-023-02482-5. Epub 2023 May 3.
- The CSR synopsis\_D169AR00003Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Navdeep Tangri principal investigator
University of Manitoba
13 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by AstraZeneca at 13 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Australia, Brazil, Canada, China and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of undiagnosed stage 3 chronic kidney disease (CKD) (time frame: From 2015 assessed throughout the study, up to a maximum of 8 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04847531, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.