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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease

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.

• Study Type: Observational
• Enrollment (Actual): 1052

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Research Site
  • Modena, Italy, 41124
    • Research Site
  • Napoli, Italy, 80138
    • Research Site
  • Lazio
    • Roma, Lazio, Italy, 00161
      • Research Site
  • Lombardia
    • Milano, Lombardia, Italy, 20156
      • Research Site
• Japan
  • Kumamoto, Japan, 860-8556
    • Research Site
  • Okayama, Japan, 700-8558
    • Research Site
  • Aiti [Aichi]
    • Nagoya, Aiti [Aichi], Japan, 466-8560
      • Research Site
  • Nara
    • Kashihara-Shi, Nara, Japan, 634-8522
      • Research Site
  • Okayama
    • Kurashiki, Okayama, Japan, 701-0192
      • Research Site
  • Tôkyô [Tokyo]
    • Itabashi-Ku, Tôkyô [Tokyo], Japan, 173-0003
      • Research Site
  • Ôsaka [Osaka]
    • Osaka, Ôsaka [Osaka], Japan, 545-0051
      • Research Site
• Spain
  • Barcelona, Spain, 08041
    • Research Site
  • Lleida, Spain, 25198
    • Research Site
  • Madrid, Spain, 28007
    • Research Site
  • Sevilla, Spain, 41950
    • Research Site
  • A Coruña
    • Ferrol, A Coruña, Spain, 15401
      • Research Site
    • Santiago de Compostela, A Coruña, Spain, 15706
      • Research Site
    • Vigo, A Coruña, Spain, 36213
      • Research Site
  • Catalunya
    • Manresa, Catalunya, Spain, 08243
      • Research Site
  • Guipúzcoa
    • Donostia, Guipúzcoa, Spain, 20014
      • Research Site
• Sweden
  • Linkoping
    • Linköping, Linkoping, Sweden, 58185
      • Research Site
  • Skåne Län [se-12]
    • Lund, Skåne Län [se-12], Sweden, 222 21
      • Research Site
  • Stockholms Län [se-01]
    • Danderyd, Stockholms Län [se-01], Sweden, 182 57
      • Research Site
    • Stockholm, Stockholms Län [se-01], Sweden, 14186
      • Research Site
• United Kingdom
  • Camden.
    • London, Camden., United Kingdom, NW3 2QG
      • Research Site
  • East Riding Of Yorkshire
    • Hull, East Riding Of Yorkshire, United Kingdom, HU3 2JZ
      • Research Site
  • Greater Manchester
    • Salford, Greater Manchester, United Kingdom, M6 8HD
      • Research Site
  • London, City Of
    • London, London, City Of, United Kingdom, EC1A 7BE
      • Research Site
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
      • Research Site
  • Wiltshire
    • Chippenham, Wiltshire, United Kingdom, SN15 2SB
      • Research Site
  • Yorkshire
    • Leeds,, Yorkshire, United Kingdom, LS9 7TF
      • Research Site
• United States
  • California
    • Riverside, California, United States, 92505-3071
      • Research Site
    • San Francisco, California, United States, 94110-3518
      • Research Site
  • Florida
    • Sanford, Florida, United States, 32771
      • Research Site
    • Sebring, Florida, United States, 33870-1216
      • Research Site
  • Massachusetts
    • Plymouth, Massachusetts, United States, 02360
      • Research Site
  • New York
    • Bronx, New York, United States, 10461-1900
      • Research Site
    • Manhasset, New York, United States, 11030-3816
      • Research Site
  • Oregon
    • Roseburg, Oregon, United States, 97471-8830
      • Research Site
  • Texas
    • El Paso, Texas, United States, 79902-4821
      • Research Site
    • Houston, Texas, United States, 77099
      • Research Site
    • San Antonio, Texas, United States, 78229
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with CKD with comorbidities and other patient characteristics	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	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]	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	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	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	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	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	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	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	Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up
Prevalence of clinical outcomes	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	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 clinical outcomes	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	Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up
Hazard ratio of clinical outcomes	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	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 prescribed different treatments related to CKD and associated comorbidities	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	Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up
Describing cost associated with utilizing healthcare resources for CKD	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	Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up
Health related quality of life as assessed using the SF-36 questionnaire	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	Prospective cohort: From baseline up to approximately 3 years
Physical activity as assessed using RAPA questionnaire	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	Prospective cohort: From baseline up to approximately 3 years
Diet assessed using food dairies	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	Prospective cohort: From baseline up to approximately 3 years
Work productivity as assessed WPAI	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	Prospective cohort: From baseline up to approximately 3 years
Describing patient specific symptoms	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	Prospective cohort: From baseline up to approximately 3 years
Describing patient experiences with CKD via qualitative interviews	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	Prospective cohort: From baseline up to approximately 3 years
Number of deaths	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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in laboratory values over time	Describing trajectories in laboratory variables over time stratified for example by: CKD stage, select demographic characteristics, country and comorbidity status including, hyperkalemia, anemia, and diabetes status	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	Exploring and identifying risk factors associated with CKD and other comorbidities stratified for example by: CKD stage, select demographic characteristics, country and comorbidity status including, hyperkalemia, anemia, and diabetes status	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	To evaluate compliance of questionnaire completion, data on number of patients using mobile phone/tablet application will be collected	Prospective cohort: From baseline up to approximately 3 years

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• 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.

Helpful Links

• CSR Synopsis_Redacted

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2019
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: July 26, 2019
• First Posted (Actual): July 29, 2019

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Observational study; Real-world data; Prospective and retrospective data capture; DISCOVER CKD
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: D1843R00291

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing 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.
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No