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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04034992
Other study ID # D1843R00291
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 11, 2019
Est. completion date June 30, 2023

Study information

Verified date February 2024
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

DISCOVER CKD is an international observational cohort study in patients with CKD, comprising both prospective and retrospective patient cohorts. The study does not attempt to test any specific a priori hypotheses, is largely descriptive, and utilises data collected only under conditions of routine clinical care.


Description:

DISCOVER CKD is an international observational cohort study in CKD patients, comprising both prospective and retrospective patient cohorts. The study does not attempt to test any specific a priori hypotheses, is largely descriptive, and utilises data collected only under conditions of routine clinical care. No additional invasive clinical tests or procedures are mandated per study protocol, and all data collected/extracted is based solely on observations of disease management and treatment decisions made between the treating physicians and their patients, and is not intended to be interventional in anyway. Patients will not receive any experimental intervention or experimental treatment as a result of participating in this study. Analyses will be conducted separately for prospective and retrospective CKD cohorts (via interim reports), and then in aggregate by combining prospective and retrospective data, to the extent possible, at the end of the study.


Recruitment information / eligibility

Status Completed
Enrollment 1052
Est. completion date June 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 130 Years
Eligibility Inclusion Criteria: 1. For all countries, except Japan: Male or female patients aged 18 years and over. For Japan: Male or female patients aged 20 years and over. 2. First documented diagnostic code (eg, International Classification of Diseases-10) of CKD (Stages 3A, 3B, 4, 5, or end stage renal disease) or two measures of eGFR of <75mL/min/1.73 m^2 recorded at least 90 days apart on or after 1 January 2008, or a code for chronic Renal replacement therapy (hemodialysis and peritoneal dialysis), whichever comes first. 3. Provision of written informed consent - specific for prospective data capture. Exclusion Criteria: 1. Concurrent participation in any interventional trial at baseline (index) (prospective only). To be implemented based on local regulatory requirements. 2. The patient is undergoing treatment for active cancer, except for non-melanoma skin cancer. 3. Patients with a life expectancy of less than 12 months (prospective only). 4. Diagnosis of cancer on or within the 1-year prior to index (retrospective only). 5. Less than 1-year registration/medical history (pre-index) (retrospective only).

Study Design


Locations

Country Name City State
Italy Research Site Bologna
Italy Research Site Milano Lombardia
Italy Research Site Modena
Italy Research Site Napoli
Italy Research Site Roma Lazio
Japan Research Site Itabashi-Ku Tôkyô [Tokyo]
Japan Research Site Kashihara-Shi Nara
Japan Research Site Kumamoto
Japan Research Site Kurashiki Okayama
Japan Research Site Nagoya Aiti [Aichi]
Japan Research Site Okayama
Japan Research Site Osaka Ôsaka [Osaka]
Spain Research Site Barcelona
Spain Research Site Donostia Guipúzcoa
Spain Research Site Ferrol A Coruña
Spain Research Site Lleida
Spain Research Site Madrid
Spain Research Site Manresa Catalunya
Spain Research Site Santiago de Compostela A Coruña
Spain Research Site Sevilla
Spain Research Site Vigo A Coruña
Sweden Research Site Danderyd Stockholms Län [se-01]
Sweden Research Site Linköping Linkoping
Sweden Research Site Lund Skåne Län [se-12]
Sweden Research Site Stockholm Stockholms Län [se-01]
United Kingdom Research Site Chippenham Wiltshire
United Kingdom Research Site Hull East Riding Of Yorkshire
United Kingdom Research Site Leeds, Yorkshire
United Kingdom Research Site London London, City Of
United Kingdom Research Site London Camden.
United Kingdom Research Site Nottingham Nottinghamshire
United Kingdom Research Site Salford Greater Manchester
United States Research Site Bronx New York
United States Research Site El Paso Texas
United States Research Site Houston Texas
United States Research Site Manhasset New York
United States Research Site Plymouth Massachusetts
United States Research Site Riverside California
United States Research Site Roseburg Oregon
United States Research Site San Antonio Texas
United States Research Site San Francisco California
United States Research Site Sanford Florida
United States Research Site Sebring Florida

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Italy,  Japan,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Changes in laboratory values over time Describing trajectories in laboratory variables over time stratified for example by: CKD stage, select demographic characteristics, country and comorbidity status including, hyperkalemia, anemia, and diabetes status Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up
Other Risk factors associated with CKD Exploring and identifying risk factors associated with CKD and other comorbidities stratified for example by: CKD stage, select demographic characteristics, country and comorbidity status including, hyperkalemia, anemia, and diabetes status Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up
Other Number of patients using a mobile phone/tablet application To evaluate compliance of questionnaire completion, data on number of patients using mobile phone/tablet application will be collected Prospective cohort: From baseline up to approximately 3 years
Primary Construct a cohort of patients with CKD Construct a multinational longitudinal cohort of patients with CKD that can be used for primary and secondary analyses Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up
Secondary Number of patients with CKD with comorbidities and other patient characteristics Describe patient characteristics including demographics, clinical assessments, family history, procedures, laboratory measurements, treatment patterns and adherence, healthcare resource utilization and clinical history (comorbidities) stratified for example by: CKD stage, select demographic characteristics, country and comorbidity status including, hyperkalemia, anemia, and diabetes status Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up
Secondary Change in estimated glomerular filtration rate [eGFR] To evaluate disease progression using retrospective and prospective data from the multinational longitudinal cohort of patients with CKD stratified for example by: CKD stage, select demographic characteristics, country and comorbidity status including, hyperkalemia, anemia, and diabetes status Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up
Secondary Time to end-stage kidney disease To evaluate disease progression using retrospective and prospective data from the multinational longitudinal cohort of patients with CKD stratified for example by: CKD stage, select demographic characteristics, country and comorbidity status including, hyperkalemia, anemia, and diabetes status Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up
Secondary Time to incident clinical outcomes To evaluate disease progression using retrospective and prospective data from the multinational longitudinal cohort of patients with CKD stratified for example by: CKD stage, select demographic characteristics, country and comorbidity status including, hyperkalemia, anemia, and diabetes status Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up
Secondary Incidence of clinical outcomes To evaluate clinical outcomes using retrospective and prospective data from the multinational longitudinal cohort of patients with CKD stratified for example by: CKD stage, select demographic characteristics, country and comorbidity status including, hyperkalemia, anemia, and diabetes status Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up
Secondary Prevalence of clinical outcomes To evaluate clinical outcomes using retrospective and prospective data from the multinational longitudinal cohort of patients with CKD stratified for example by: CKD stage, select demographic characteristics, country and comorbidity status including, hyperkalemia, anemia, and diabetes status Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up
Secondary Time to clinical outcomes To evaluate clinical outcomes using retrospective and prospective data from the multinational longitudinal cohort of patients with CKD stratified for example by: CKD stage, select demographic characteristics, country and comorbidity status including, hyperkalemia, anemia, and diabetes status Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up
Secondary Hazard ratio of clinical outcomes To evaluate clinical outcomes using retrospective and prospective data from the multinational longitudinal cohort of patients with CKD stratified for example by: CKD stage, select demographic characteristics, country and comorbidity status including, hyperkalemia, anemia, and diabetes status Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up
Secondary Number of patients prescribed different treatments related to CKD and associated comorbidities To understand the treatment practice and medication adherence using retrospective and prospective data from the multinational longitudinal cohort of patients with CKD stratified for example by: CKD stage, select demographic characteristics, country and comorbidity status including, hyperkalemia, anemia, and diabetes status Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up
Secondary Describing cost associated with utilizing healthcare resources for CKD To understand the healthcare resource use and cost using retrospective and prospective data from the multinational longitudinal cohort of patients with CKD stratified for example by: CKD stage, select demographic characteristics, country and comorbidity status including, hyperkalemia, anemia, and diabetes status Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up
Secondary Health related quality of life as assessed using the SF-36 questionnaire Patient specific data will be collected in a prospective manner in the multinational longitudinal cohort of patients with CKD stratified for example by: CKD stage, select demographic characteristics, country and comorbidity status including, hyperkalemia, anemia, and diabetes status. The SF-36 is a multipurpose questionnaire with 36 questions to measure status of different health domains Prospective cohort: From baseline up to approximately 3 years
Secondary Physical activity as assessed using RAPA questionnaire Patient specific data will be collected in a prospective manner in the multinational longitudinal cohort of patients with CKD stratified for example by: CKD stage, select demographic characteristics, country and comorbidity status including, hyperkalemia, anemia, and diabetes status. The RAPA is a self-administered questionnaire consisting of 9 binary (yes or no) questions to understand level of physical activity by an individual Prospective cohort: From baseline up to approximately 3 years
Secondary Diet assessed using food dairies Patient specific data will be collected in a prospective manner in the multinational longitudinal cohort of patients with CKD stratified for example by: CKD stage, select demographic characteristics, country and comorbidity status including, hyperkalemia, anemia, and diabetes status Prospective cohort: From baseline up to approximately 3 years
Secondary Work productivity as assessed WPAI Patient specific data will be collected in a prospective manner in the multinational longitudinal cohort of patients with CKD stratified for example by: CKD stage, select demographic characteristics, country and comorbidity status including, hyperkalemia, anemia, and diabetes status. The WPAI questionnaire consists of 6 questions to assess the impact of disease on work productivity Prospective cohort: From baseline up to approximately 3 years
Secondary Describing patient specific symptoms Patient specific data will be collected in a prospective manner in the multinational longitudinal cohort of patients with CKD stratified for example by: CKD stage, select demographic characteristics, country and comorbidity status including, hyperkalemia, anemia, and diabetes status Prospective cohort: From baseline up to approximately 3 years
Secondary Describing patient experiences with CKD via qualitative interviews Patient specific data will be collected in a prospective manner in the multinational longitudinal cohort of patients with CKD stratified for example by: CKD stage, select demographic characteristics, country and comorbidity status including, hyperkalemia, anemia, and diabetes status Prospective cohort: From baseline up to approximately 3 years
Secondary Number of deaths Information of death (including cause of death) will be obtained stratified for example by: CKD stage, select demographic characteristics, country and comorbidity status including, hyperkalemia, anemia, and diabetes status Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up
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