Clinical trial NCT04034992: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Keywords: Observational study
Real-world data
Prospective and retrospective data capture
DISCOVER CKD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2019-07-29
Enrollment: 1052
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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).

Primary outcomes:
measure: Construct a cohort of patients with CKD
timeFrame: 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:
measure: Number of patients with CKD with comorbidities and other patient characteristics
timeFrame: Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up
measure: Change in estimated glomerular filtration rate [eGFR]
timeFrame: Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up
measure: Time to end-stage kidney disease
timeFrame: Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up
measure: Time to incident clinical outcomes
timeFrame: Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up
measure: Incidence of clinical outcomes
timeFrame: Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up
measure: Prevalence of clinical outcomes
timeFrame: Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up
measure: Time to clinical outcomes
timeFrame: Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up
measure: Hazard ratio of clinical outcomes
timeFrame: Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up
measure: Number of patients prescribed different treatments related to CKD and associated comorbidities
timeFrame: Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up
measure: Describing cost associated with utilizing healthcare resources for CKD
timeFrame: Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up
measure: Health related quality of life as assessed using the SF-36 questionnaire
timeFrame: Prospective cohort: From baseline up to approximately 3 years
measure: Physical activity as assessed using RAPA questionnaire
timeFrame: Prospective cohort: From baseline up to approximately 3 years
measure: Diet assessed using food dairies
timeFrame: Prospective cohort: From baseline up to approximately 3 years
measure: Work productivity as assessed WPAI
timeFrame: Prospective cohort: From baseline up to approximately 3 years
measure: Describing patient specific symptoms
timeFrame: Prospective cohort: From baseline up to approximately 3 years
measure: Describing patient experiences with CKD via qualitative interviews
timeFrame: Prospective cohort: From baseline up to approximately 3 years
measure: Number of deaths
timeFrame: 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 outcomes:
measure: Changes in laboratory values over time
timeFrame: Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up
measure: Risk factors associated with CKD
timeFrame: Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up
measure: Number of patients using a mobile phone/tablet application
timeFrame: Prospective cohort: From baseline up to approximately 3 years
Locations:
city: Riverside
country: United States
facility: Research Site
state: California
city: San Francisco
country: United States
facility: Research Site
state: California
city: Sanford
country: United States
facility: Research Site
state: Florida
city: Sebring
country: United States
facility: Research Site
state: Florida
city: Plymouth
country: United States
facility: Research Site
state: Massachusetts
city: Bronx
country: United States
facility: Research Site
state: New York
city: Manhasset
country: United States
facility: Research Site
state: New York
city: Roseburg
country: United States
facility: Research Site
state: Oregon
city: El Paso
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Roma
country: Italy
facility: Research Site
state: Lazio
city: Milano
country: Italy
facility: Research Site
state: Lombardia
city: Bologna
country: Italy
facility: Research Site
city: Modena
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Nagoya
country: Japan
facility: Research Site
state: Aiti [Aichi]
city: Kashihara-Shi
country: Japan
facility: Research Site
state: Nara
city: Kurashiki
country: Japan
facility: Research Site
state: Okayama
city: Itabashi-Ku
country: Japan
facility: Research Site
state: Tôkyô [Tokyo]
city: Kumamoto
country: Japan
facility: Research Site
city: Okayama
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
state: Ôsaka [Osaka]
city: Ferrol
country: Spain
facility: Research Site
state: A Coruña
city: Santiago de Compostela
country: Spain
facility: Research Site
state: A Coruña
city: Vigo
country: Spain
facility: Research Site
state: A Coruña
city: Manresa
country: Spain
facility: Research Site
state: Catalunya
city: Donostia
country: Spain
facility: Research Site
state: Guipúzcoa
city: Barcelona
country: Spain
facility: Research Site
city: Lleida
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Linköping
country: Sweden
facility: Research Site
state: Linkoping
city: Lund
country: Sweden
facility: Research Site
state: Skåne Län [se-12]
city: Danderyd
country: Sweden
facility: Research Site
state: Stockholms Län [se-01]
city: Stockholm
country: Sweden
facility: Research Site
state: Stockholms Län [se-01]
city: London
country: United Kingdom
facility: Research Site
state: Camden.
city: Hull
country: United Kingdom
facility: Research Site
state: East Riding Of Yorkshire
city: Salford
country: United Kingdom
facility: Research Site
state: Greater Manchester
city: London
country: United Kingdom
facility: Research Site
state: London, City Of
city: Nottingham
country: United Kingdom
facility: Research Site
state: Nottinghamshire
city: Chippenham
country: United Kingdom
facility: Research Site
state: Wiltshire
city: Leeds,
country: United Kingdom
facility: Research Site
state: Yorkshire
Study officials:
References:
citation: James G, Garcia Sanchez JJ, Carrero JJ, Kumar S, Pecoits-Filho R, Heerspink HJL, Nolan S, Lam CSP, Chen H, Kanda E, Kashihara N, Arnold M, Kosiborod MN, Lainscak M, Pollock C, Wheeler DC. Low Adherence to Kidney Disease: Improving Global Outcomes 2012 CKD Clinical Practice Guidelines Despite Clear Evidence of Utility. Kidney Int Rep. 2022 Jun 8;7(9):2059-2070. doi: 10.1016/j.ekir.2022.05.033. eCollection 2022 Sep.
citation: Pollock C, James G, Garcia Sanchez JJ, Arnold M, Carrero JJ, Lam CSP, Chen H, Nolan S, Pecoits-Filho R. Cost of End-of-Life Inpatient Encounters in Patients with Chronic Kidney Disease in the United States: A Report from the DISCOVER CKD Retrospective Cohort. Adv Ther. 2022 Mar;39(3):1432-1445. doi: 10.1007/s12325-021-02010-3. Epub 2022 Feb 3.