Clinical trial NCT04847531: REVEAL-CKD: Prevalence and Consequences of Undiagnosed Chronic Kidney Disease
Official title: REVEAL-CKD: A Retrospective, Multinational Observational Study to Determine the Prevalence and Consequences of Undiagnosed Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-04-19
Enrollment: 1006361
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

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

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of undiagnosed stage 3 chronic kidney disease (CKD)
timeFrame: From 2015 assessed throughout the study, up to a maximum of 8 years
measure: Time to CKD diagnosis
timeFrame: 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:
measure: Describe proportion of patients comorbidities and other patient characteristics
timeFrame: From 2015 assessed throughout the study, up to a maximum of 8 years
measure: Proportion of patients monitored for kidney function and complications
timeFrame: 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
measure: Proportion of patients tested for CKD
timeFrame: 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
measure: Proportion of patients prescribed selected medications
timeFrame: 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
measure: Proportion of patients monitored for high blood pressure
timeFrame: 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
measure: Proportion of patients monitored for glycaemic control
timeFrame: 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
measure: Proportion of patients receiving kidney function monitoring after initiation of angiotensin receptor blocker or angiotensin converting enzyme inhibitors
timeFrame: 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
Other outcomes:
measure: Incidence of adverse renal events
timeFrame: 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
measure: Incidence of all-cause mortality
timeFrame: 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
measure: CKD progression
timeFrame: 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
measure: Incidence of Cardiovascular (CV) events
timeFrame: 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
measure: Describe health care resource utilisation and associated costs
timeFrame: From six months after the second abnormal eGFR, assessed throughout the study until end of follow-up, up to a maximum of 5 years
Locations:
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: Cambridge
country: United States
facility: Research Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Sydney
country: Australia
facility: Research Site
state: New South Wales
city: Sao Paulo
country: Brazil
facility: Research Site
city: Kingston
country: Canada
facility: Research Site
state: Ontario
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Boulogne-Billancourt
country: France
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Milan
country: Italy
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
state: Greater London
Study officials:
affiliation: University of Manitoba
name: Navdeep Tangri
role: PRINCIPAL_INVESTIGATOR
References: