A Study on Patients With Chronic Kidney Disease (CKD) to Assess Treatment Experience and Patterns, Effect of the Treatment, Patient Outcomes and Patient Quality of Life

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Observational Study Collecting Real-world Data on Patients With Chronic Kidney Disease to Assess: Early Treatment Experience, Treatment Patterns, Treatment Effectiveness, Patient Outcomes and Patient Quality of Life Through Prospective and Retrospective Data Capture

Conditions
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Chronic Kidney Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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. Provision of written informed consent - specific for prospective data capture. Exclusion Criteria: Concurrent participation in any interventional trial at baseline (index) (prospective only). To be implemented based on local regulatory requirements. The patient is undergoing treatment for active cancer, except for non-melanoma skin cancer. Patients with a life expectancy of less than 12 months (prospective only). Diagnosis of cancer on or within the 1-year prior to index (retrospective only). Less than 1-year registration/medical history (pre-index) (retrospective only).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 130 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective CKD cohort<br>Retrospective (secondary) data refers to patient data extracted from existing electronic health records (EHRs)/registries/databases. It represents existing real-world data, regardless of reason for collection or location of storage and is analogous to those represented in the study protocol for which feasibility assessments are conducted. Retrospective data will be collected from registries, databases, and EHRs. The aim is to identify and extract clinical data retrospectively from a minimum of 100000 (no set maximum) CKD patients via existing databases/registries/EHRs across geographies. The retrospective data will be captured beginning 1 January 2008 through the most currently available data. | |
| Prospective CKD cohort<br>Prospective (primary and secondary) data refers to manual collection/extraction of data in a de novo manner for the purpose of addressing study objectives. Collection/extraction of patient data in the prospective cohort will be done via electronic case report form, questionnaires, and mobile phone/tablet application. The initial aim is to identify and collect/extract data from approximately 1000 (no set maximum) enrolled CKD patients until the decision to stop the study is taken, with the possibility of prospective follow-up for a minimum of approximately 1 year up to a maximum of approximately 3 years. The patient specific data in the prospective cohort will be collected by utilizing Rapid Assessment of Physical Activity (RAPA) questionnaire, Work Productivity and Activity Impairment (WPAI) questionnaire, Short Form (SF)-36 questionnaires, simple food diary, and other patient reported outcomes - including a set of questions to collect patient symptoms. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Observational study, Real-world data, Prospective and retrospective data capture, DISCOVER CKD