Skip to main content
OpenTrials
Completed

NCT Number: NCT04847531

REVEAL-CKD: 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Sydney, New South Wales, Australia

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Describe proportion of patients comorbidities and other patient characteristics

    Time frame: From 2015 assessed throughout the study, up to a maximum of 8 years

    Describe patient characteristics including demographics, clinical assessments, family history, procedures, laboratory measurements, treatment patterns and clinical history (comorbidities) stratified by CKD diagnosis status

  2. 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

    • Serum Cr test (outpatient)
    • Patients receiving a UACR test (outpatient)
    • Serum calcium
    • Phosphate
    • Albumin
    • Bicarbonate
    • Potassium
    • Hemoglobin
    • Albuminuria

  3. 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

    • UACR test

  4. 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

    • Statin prescription
    • Angiotensin converting enzyme inhibitors (ACEis) or angiotensin receptor blockers (ARBs)
    • Sodium-glucose cotransporter-2 (SGLT2) inhibitors
    • Vaccination (influenza)

  5. 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

    • Patients receiving BP measurement
    • BP measurement ≤140/90
    • BP measurement ≤ 130/80 in patients with evidence of albuminuria and/or diabetes

  6. 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

    • HbA1c test in patients with diabetes

  7. 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

    • An outpatient serum creatinine measurement

Other outcomes

  1. Incidence of adverse renal events

    Time frame: 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

    • 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)

  2. Incidence of all-cause mortality

    Time frame: 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

    All-cause mortality

  3. CKD progression

    Time frame: 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

    Progression to CKD stage 4 or higher

  4. Incidence of Cardiovascular (CV) events

    Time frame: 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

    • 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

  5. Describe health care resource utilisation and associated costs

    Time frame: From six months after the second abnormal eGFR, assessed throughout the study until end of follow-up, up to a maximum of 5 years

    To understand the healthcare resource use and cost associated with undiagnosed CKD

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: REVEAL-CKD

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 19, 2021
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.