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

NCT ID: NCT04847531

Last Updated: 2024-12-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1006361 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-15
• Study Completion Date: 2023-11-13

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

Conditions

Chronic Kidney Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Navdeep Tangri

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

Research Site

Louisville, Kentucky, United States

Research Site

Cambridge, Massachusetts, United States

Research Site

Ann Arbor, Michigan, United States

Research Site

Sydney, New South Wales, Australia

Research Site

São Paulo, , Brazil

Research Site

Kingston, Ontario, Canada

Research Site

Guangzhou, Guangdong, China

Research Site

Boulogne-Billancourt, , France

Research Site

Frankfurt, , Germany

Research Site

Milan, , Italy

Research Site

Kyoto, , Japan

Research Site

Madrid, , Spain

Research Site

London, Greater London, United Kingdom

Countries

United States; Australia; Brazil; Canada; China; France; Germany; Italy; Japan; Spain; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 37217263 (View on PubMed)

Tangri 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.

Reference Type: DERIVED

PMID: 37133647 (View on PubMed)

Related Links

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D169AR00003&amp;attachmentIdentifier=562af12c-16b4-4aeb-afa2-ceeee0ccaf80&amp;fileName=REVEAL_CKD_study_report_synopsis_D169AR00003.pdf&amp;versionIdentifier=

The CSR synopsis\_D169AR00003

Other Identifiers

D169AR00003

Identifier Type: -

Identifier Source: org_study_id