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
NCT ID: NCT04034992
Last Updated: 2024-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1052 participants
OBSERVATIONAL
2019-09-11
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Retrospective CKD cohort
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.
No interventions assigned to this group
Prospective CKD cohort
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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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
Research Site
San Antonio, Texas, United States
Research Site
Rome, Lazio, Italy
Research Site
Milan, Lombardy, Italy
Research Site
Bologna, , Italy
Research Site
Modena, , Italy
Research Site
Napoli, , Italy
Research Site
Nagoya, Aiti [Aichi], Japan
Research Site
Kashihara-shi, Nara, Japan
Research Site
Kurashiki, Okayama-ken, Japan
Research Site
Itabashi-Ku, Tôkyô [Tokyo], Japan
Research Site
Kumamoto, , Japan
Research Site
Okayama, , Japan
Research Site
Osaka, Ôsaka [Osaka], Japan
Research Site
Ferrol, A Coruña, Spain
Research Site
Santiago de Compostela, A Coruña, Spain
Research Site
Vigo, A Coruña, Spain
Research Site
Manresa, Catalonia, Spain
Research Site
Donostia / San Sebastian, Guipúzcoa, Spain
Research Site
Barcelona, , Spain
Research Site
Lleida, , Spain
Research Site
Madrid, , Spain
Research Site
Seville, , Spain
Research Site
Linköping, Linkoping, Sweden
Research Site
Lund, Skåne Län [se-12], Sweden
Research Site
Danderyd, Stockholms Län [se-01], Sweden
Research Site
Stockholm, Stockholms Län [se-01], Sweden
Research Site
London, Camden., United Kingdom
Research Site
Hull, East Riding Of Yorkshire, United Kingdom
Research Site
Salford, Greater Manchester, United Kingdom
Research Site
London, London, City of, United Kingdom
Research Site
Nottingham, Nottinghamshire, United Kingdom
Research Site
Chippenham, Wiltshire, United Kingdom
Research Site
Leeds, Yorkshire, United Kingdom
Countries
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References
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Pollock C, Carrero JJ, Kanda E, Ofori-Asenso R, Chen H, Garcia Sanchez JJ, Pentakota S, Pecoits-Filho R, Fishbane S, Lam CSP, Kashihara N, Wheeler DC. Baseline Characteristics of the DISCOVER CKD Prospective Cohort. Adv Ther. 2025 Mar;42(3):1393-1418. doi: 10.1007/s12325-024-03028-z. Epub 2024 Nov 29.
Fishbane S, Carrero JJ, Kumar S, Kanda E, Hedman K, Ofori-Asenso R, Kashihara N, Kosiborod MN, Lainscak M, Pollock C, Stenvinkel P, Wheeler DC, Pecoits-Filho R. Hyperkalemia Burden and Treatment Pathways in Patients with CKD: Findings From the DISCOVER CKD Retrospective Cohort. Kidney360. 2024 Jul 1;5(7):974-986. doi: 10.34067/KID.0000000000000468. Epub 2024 May 28.
Heerspink H, Nolan S, Carrero JJ, Arnold M, Pecoits-Filho R, Garcia Sanchez JJ, Wittbrodt E, Cabrera C, Lam CSP, Chen H, Kanda E, Lainscak M, Pollock C, Wheeler DC. Clinical Outcomes in Patients with CKD and Rapid or Non-rapid eGFR Decline: A Report from the DISCOVER CKD Retrospective Cohort. Adv Ther. 2024 Aug;41(8):3264-3277. doi: 10.1007/s12325-024-02913-x. Epub 2024 Jul 3.
Pollock C, Sanchez JJG, Carrero JJ, Kumar S, Pecoits-Filho R, Lam CSP, Chen H, Kanda E, Lainscak M, Wheeler DC. Glucose-lowering treatment pathways of individuals with chronic kidney disease and type 2 diabetes according to the Kidney Disease: Improving Global Outcomes 2012 risk classification. Diabet Med. 2024 Feb;41(2):e15200. doi: 10.1111/dme.15200. Epub 2023 Aug 26.
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.
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.
Related Links
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Other Identifiers
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D1843R00291
Identifier Type: -
Identifier Source: org_study_id
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