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.
Brief Title
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
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Chronic Kidney Disease
Eligibility Criteria
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).
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).
Inclusion Criteria
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.
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.
Gender
All
Gender Based
false
Keywords
Observational study
Real-world data
Prospective and retrospective data capture
DISCOVER CKD
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
130 Years
Minimum Age
18 Years
NCT Id
NCT04034992
Org Class
Industry
Org Full Name
AstraZeneca
Org Study Id
D1843R00291
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
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
Primary Outcomes
Outcome Description
Construct a multinational longitudinal cohort of patients with CKD that can be used for primary and secondary analyses
Outcome Measure
Construct a cohort of patients with CKD
Outcome 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
Outcome Description
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
Outcome 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
Outcome Measure
Number of patients with CKD with comorbidities and other patient characteristics
Outcome Description
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
Outcome 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
Outcome Measure
Change in estimated glomerular filtration rate [eGFR]
Outcome Description
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
Outcome 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
Outcome Measure
Time to end-stage kidney disease
Outcome Description
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
Outcome 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
Outcome Measure
Time to incident clinical outcomes
Outcome Description
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
Outcome 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
Outcome Measure
Incidence of clinical outcomes
Outcome Description
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
Outcome 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
Outcome Measure
Prevalence of clinical outcomes
Outcome Description
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
Outcome 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
Outcome Measure
Time to clinical outcomes
Outcome Description
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
Outcome 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
Outcome Measure
Hazard ratio of clinical outcomes
Outcome Description
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
Outcome 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
Outcome Measure
Number of patients prescribed different treatments related to CKD and associated comorbidities
Outcome Description
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
Outcome 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
Outcome Measure
Describing cost associated with utilizing healthcare resources for CKD
Outcome Description
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
Outcome Time Frame
Prospective cohort: From baseline up to approximately 3 years
Outcome Measure
Health related quality of life as assessed using the SF-36 questionnaire
Outcome Description
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
Outcome Time Frame
Prospective cohort: From baseline up to approximately 3 years
Outcome Measure
Physical activity as assessed using RAPA questionnaire
Outcome Description
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
Outcome Time Frame
Prospective cohort: From baseline up to approximately 3 years
Outcome Measure
Diet assessed using food dairies
Outcome Description
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
Outcome Time Frame
Prospective cohort: From baseline up to approximately 3 years
Outcome Measure
Work productivity as assessed WPAI
Outcome Description
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
Outcome Time Frame
Prospective cohort: From baseline up to approximately 3 years
Outcome Measure
Describing patient specific symptoms
Outcome Description
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
Outcome Time Frame
Prospective cohort: From baseline up to approximately 3 years
Outcome Measure
Describing patient experiences with CKD via qualitative interviews
Outcome Description
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
Outcome 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
Outcome Measure
Number of deaths
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
For prospective (primary and secondary) data collection/extraction, all individuals with CKD fulfilling the inclusion criteria but none of the exclusion criteria will be considered; attempts will be made to enrich the data collection/extraction of patient samples by ensuring sufficient numbers of each CKD stage with comorbidities including diabetes mellitus, heart failure, coronary artery disease, etc.
For retrospective (secondary) data extraction, all individuals with CKD fulfilling the inclusion criteria and who have at least 1-year of medical history (within the selected registry, EHR, or database) prior to baseline (index) date will be considered.
For retrospective (secondary) data extraction, all individuals with CKD fulfilling the inclusion criteria and who have at least 1-year of medical history (within the selected registry, EHR, or database) prior to baseline (index) date will be considered.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
130
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Matthew Abramowitz
Investigator Email
matthew.abramowitz@einsteinmed.org