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

NCT04847531 | Completed

• 1 other identifier: D169AR00003
• Study Type: observational
• Target: 1,006,361
• Locations: 11 countries
• Sites: 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

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (2)

• 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

  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

  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

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

• Proportion of patients monitored for kidney function and complications

  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

  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

  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

  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 (5)

• Incidence of adverse renal events

  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

• Incidence of all-cause mortality

  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

• CKD progression

  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

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (13)

Research Site

Louisville, Kentucky, 40202, United States

Location

Research Site

Cambridge, Massachusetts, 02140, United States

Location

Research Site

Ann Arbor, Michigan, 48108, United States

Location

Research Site

Sydney, New South Wales, 2040, Australia

Location

Research Site

São Paulo, 05403-000, Brazil

Location

Research Site

Kingston, Ontario, K7L 3G2, Canada

Location

Research Site

Guangzhou, Guangdong, 510515, China

Location

Research Site

Boulogne-Billancourt, 92641, France

Location

Research Site

Frankfurt, 60549, Germany

Location

Research Site

Milan, 20124, Italy

Location

Research Site

Kyoto, 604-0086, Japan

Location

Research Site

Madrid, 28037, Spain

Location

Research Site

London, Greater London, E14 4PU, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 37217263 DERIVED

• 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.

  PMID: 37133647 DERIVED

Related Links

• The CSR synopsis\_D169AR00003

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Navdeep Tangri

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 19, 2021
• Study Start: December 15, 2020
• Primary Completion: November 13, 2023
• Study Completion: November 13, 2023
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

US (3); JP (1); CA (1); DE (1); GB (1); IT (1); AU (1); BR (1); CN (1); ES (1); FR (1)