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

NCT04034992 | Completed

• 1 other identifier: D1843R00291
• Study Type: observational
• Target: 1,052
• Locations: 6 countries
• Sites: 43

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.

Conditions

Chronic Kidney Disease

Keywords

Observational study; Real-world data; Prospective and retrospective data capture; DISCOVER CKD

Outcome Measures

Primary Outcomes (1)

• 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

  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 (17)

• 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

• 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

• 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

• 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

• 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

Other Outcomes (3)

• Changes in laboratory values over time

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

• Risk factors associated 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

• Number of patients using a mobile phone/tablet application

  Prospective cohort: From baseline up to approximately 3 years

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (43)

Research Site

Riverside, California, 92505-3071, United States

Location

Research Site

San Francisco, California, 94110-3518, United States

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Research Site

Sanford, Florida, 32771, United States

Location

Research Site

Sebring, Florida, 33870-1216, United States

Location

Research Site

Plymouth, Massachusetts, 02360, United States

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Research Site

Manhasset, New York, 11030-3816, United States

Location

Research Site

The Bronx, New York, 10461-1900, United States

Location

Research Site

Roseburg, Oregon, 97471-8830, United States

Location

Research Site

El Paso, Texas, 79902-4821, United States

Location

Research Site

Houston, Texas, 77099, United States

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Research Site

San Antonio, Texas, 78229, United States

Location

Research Site

Rome, Lazio, 00161, Italy

Location

Research Site

Milan, Lombardy, 20156, Italy

Location

Research Site

Bologna, 40138, Italy

Location

Research Site

Modena, 41124, Italy

Location

Research Site

Napoli, 80138, Italy

Location

Research Site

Nagoya, Aiti [Aichi], 466-8560, Japan

Location

Research Site

Kashihara-shi, Nara, 634-8522, Japan

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Research Site

Kurashiki, Okayama-ken, 701-0192, Japan

Location

Research Site

Itabashi-Ku, Tôkyô [Tokyo], 173-0003, Japan

Location

Research Site

Kumamoto, 860-8556, Japan

Location

Research Site

Okayama, 700-8558, Japan

Location

Research Site

Osaka, Ôsaka [Osaka], 545-0051, Japan

Location

Research Site

Ferrol, A Coruña, 15401, Spain

Location

Research Site

Santiago de Compostela, A Coruña, 15706, Spain

Location

Research Site

Vigo, A Coruña, 36213, Spain

Location

Research Site

Manresa, Catalonia, 08243, Spain

Location

Research Site

Donostia / San Sebastian, Guipúzcoa, 20014, Spain

Location

Research Site

Barcelona, 08041, Spain

Location

Research Site

Lleida, 25198, Spain

Location

Research Site

Madrid, 28007, Spain

Location

Research Site

Seville, 41950, Spain

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Research Site

Linköping, Linkoping, 58185, Sweden

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Research Site

Lund, Skåne Län [se-12], 222 21, Sweden

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Research Site

Danderyd, Stockholms Län [se-01], 182 57, Sweden

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Stockholm, Stockholms Län [se-01], 14186, Sweden

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Research Site

London, Camden., NW3 2QG, United Kingdom

Location

Research Site

Hull, East Riding Of Yorkshire, HU3 2JZ, United Kingdom

Location

Research Site

Salford, Greater Manchester, M6 8HD, United Kingdom

Location

Research Site

London, London, City of, EC1A 7BE, United Kingdom

Location

Research Site

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

Research Site

Chippenham, Wiltshire, SN15 2SB, United Kingdom

Location

Research Site

Leeds, Yorkshire, LS9 7TF, United Kingdom

Location

Related Publications (6)

• 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.

  PMID: 39611870 DERIVED

• 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.

  PMID: 39052473 DERIVED

• 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.

  PMID: 38958839 DERIVED

• 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.

  PMID: 37578188 DERIVED

• 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.

  PMID: 36090504 DERIVED

• 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.

  PMID: 35112306 DERIVED

Related Links

• CSR Synopsis\_Redacted

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 29, 2019
• Study Start: September 11, 2019
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: March 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

IT (5); GB (7); US (11); JP (7); ES (9); SE (4)