REVEAL-CKD: Prevalence and Consequences of Undiagnosed Chronic Kidney Disease

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    1000000
  • sponsor
    AstraZeneca
Updated on 15 September 2021

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

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):
  6. Estimate the point prevalence of undiagnosed CKD
  7. Describe the risk of selected adverse clinical outcomes longitudinally among those with undiagnosed CKD
  8. Describe HCRU and costs associated with undiagnosed CKD

Details
Condition chronic renal insufficiency, Chronic renal failure, chronic kidney disease, chronic kidney disease (ckd)
Clinical Study IdentifierNCT04847531
SponsorAstraZeneca
Last Modified on15 September 2021

Eligibility

Yes No Not Sure

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
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