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

AstraZeneca1,052 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,052

Conditions

Chronic Kidney Disease

Eligibility

Sex: ALLMin age: 18 YearsMax age: 130 Years

Medical Language ↔ Plain English

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).

Locations (43)

Outcomes

Primary Outcomes

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

Time frame: 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 Outcomes

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

Time frame: 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

Time frame: 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

Time frame: Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up

Data from ClinicalTrials.gov

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Research Site

Riverside, California, United States

Research Site

San Francisco, California, United States

Research Site

Sanford, Florida, United States

Research Site

Sebring, Florida, United States

Research Site

Plymouth, Massachusetts, United States

Research Site

Manhasset, New York, United States

Research Site

The Bronx, New York, United States

Research Site

Roseburg, Oregon, United States

Research Site

El Paso, Texas, United States

Research Site

Houston, Texas, United States

...and 33 more locations

Time to incident clinical outcomes

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Prospective cohort: From baseline up to approximately 3 years

Diet assessed using food dairies

Time frame: 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

Time frame: Prospective cohort: From baseline up to approximately 3 years

Describing patient specific symptoms

Time frame: Prospective cohort: From baseline up to approximately 3 years

Describing patient experiences with CKD via qualitative interviews

Time frame: 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

Time frame: Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up