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
- Conditions
- Chronic Kidney Disease
- Registration Number
- NCT04034992
- Lead Sponsor
- AstraZeneca
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1052
- 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.
- 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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Construct a cohort of patients with CKD Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up Construct a multinational longitudinal cohort of patients with CKD that can be used for primary and secondary analyses
- Secondary Outcome Measures
Name Time Method Number of patients with CKD with comorbidities and other patient characteristics Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up 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
Number of patients prescribed different treatments related to CKD and associated comorbidities Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up 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
Number of deaths Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up 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 to end-stage kidney disease Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up 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
Incidence of clinical outcomes Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up 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 to clinical outcomes Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up 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 to incident clinical outcomes Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up 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
Prevalence of clinical outcomes Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up 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
Change in estimated glomerular filtration rate [eGFR] Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up 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
Health related quality of life as assessed using the SF-36 questionnaire Prospective cohort: From baseline up to approximately 3 years 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
Physical activity as assessed using RAPA questionnaire Prospective cohort: From baseline up to approximately 3 years 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
Describing patient specific symptoms Prospective cohort: From baseline up to approximately 3 years 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
Hazard ratio of clinical outcomes Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up 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
Diet assessed using food dairies Prospective cohort: From baseline up to approximately 3 years 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
Work productivity as assessed WPAI Prospective cohort: From baseline up to approximately 3 years 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
Describing cost associated with utilizing healthcare resources for CKD Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up 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
Describing patient experiences with CKD via qualitative interviews Prospective cohort: From baseline up to approximately 3 years 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
Trial Locations
- Locations (1)
Research Site
đŸ‡¬đŸ‡§Leeds,, Yorkshire, United Kingdom