Chronic Kidney DiseaseNCT04034992
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 of Chronic Kidney Disease, run by AstraZeneca at 43 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Chronic Kidney Disease
- Type of treatment
- Pill or oral medicine
- How many people
- 1,052 participants
- Where
- 43 sitesin 6 countries
- Study dates
- 11 Sep 2019to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
43 sites in 6 countries.
43 sites in 6 countries
United States11 sites
Research Site
El Paso, Texas, 79902-4821
Research Site
Houston, Texas, 77099
Research Site
Manhasset, New York, 11030-3816
Research Site
Plymouth, Massachusetts, 02360
Research Site
Riverside, California, 92505-3071
Research Site
Roseburg, Oregon, 97471-8830
Research Site
San Antonio, Texas, 78229
Research Site
San Francisco, California, 94110-3518
Research Site
Sanford, Florida, 32771
Research Site
Sebring, Florida, 33870-1216
Research Site
The Bronx, New York, 10461-1900
Spain9 sites
Research Site
Barcelona, 08041
Research Site
Donostia / San Sebastian, Guipúzcoa, 20014
Research Site
Ferrol, A Coruña, 15401
Research Site
Lleida, 25198
Research Site
Madrid, 28007
Research Site
Manresa, Catalonia, 08243
Research Site
Santiago de Compostela, A Coruña, 15706
Research Site
Seville, 41950
Research Site
Vigo, A Coruña, 36213
Japan7 sites
Research Site
Itabashi-Ku, Tôkyô [Tokyo], 173-0003
Research Site
Kashihara-shi, Nara, 634-8522
Research Site
Kumamoto, 860-8556
Research Site
Kurashiki, Okayama-ken, 701-0192
Research Site
Nagoya, Aiti [Aichi], 466-8560
Research Site
Okayama, 700-8558
Research Site
Osaka, Ôsaka [Osaka], 545-0051
United Kingdom7 sites
Research Site
Chippenham, Wiltshire, SN15 2SB
Research Site
Hull, East Riding Of Yorkshire, HU3 2JZ
Research Site
Leeds, Yorkshire, LS9 7TF
Research Site
London, Camden., NW3 2QG
Research Site
London, London, City of, EC1A 7BE
Research Site
Nottingham, Nottinghamshire, NG5 1PB
Research Site
Salford, Greater Manchester, M6 8HD
Italy5 sites
Research Site
Bologna, 40138
Research Site
Milan, Lombardy, 20156
Research Site
Modena, 41124
Research Site
Naples, 80138
Research Site
Rome, Lazio, 00161
Sweden4 sites
Research Site
Danderyd, Stockholms Län [se-01], 182 57
Research Site
Linköping, Linkoping, 58185
Research Site
Lund, Skåne Län [se-12], 222 21
Research Site
Stockholm, Stockholms Län [se-01], 14186
About this study
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
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.
Read the 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.
- Conditions
- Chronic Kidney Disease
- Keywords
- Observational study, Real-world data, Prospective and retrospective data capture, DISCOVER CKD
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Prospective cohort: From baseline up to approximately 3 years Retrospective cohort: From 1 January 2008 up to approximately 15 years of patient follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start11 Sep 2019
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,052 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034992
- Sponsor's protocol ID
- D1843R00291
- Status last verified
- Feb 2024
- First submitted
- 3 Jul 2019
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39611870Pollock C, Carrero JJ, Kanda E, Ofori-Asenso R, Palmer E, Niklasson A, Linder A, Woodward H, Pentakota S, Garcia Sanchez JJ, Kashihara N, Fishbane S, Pecoits-Filho R, Wheeler DC. The Lived Experience of Patients with Chronic Kidney Disease: Insights From DISCOVER CKD. Am J Nephrol. 2024;55(6):618-628. doi: 10.1159/000541064. Epub 2024 Aug 22.
PubMed 39173604Fishbane 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.
PubMed 39052473Heerspink 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.
PubMed 38958839Pollock 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.
PubMed 37578188James 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.
PubMed 36090504Pollock 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.
PubMed 35112306
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04034992
- Acronym / sponsor ID
- D1843R00291
- Conditions
- Chronic Kidney Disease
- Keywords
- Observational study, Real-world data, Prospective and retrospective data capture, DISCOVER CKD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,052 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2019 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 29 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Construct a cohort of patients with CKD
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
Construct a multinational longitudinal cohort of patients with CKD that can be used for primary and secondary analyses
17 secondary outcomes
Number of patients with CKD with comorbidities and other patient characteristics
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
Change in estimated glomerular filtration rate [eGFR]
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
Time to end-stage kidney disease
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
Time to incident clinical outcomes
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
Incidence of clinical outcomes
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
Prevalence of clinical outcomes
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
Time to clinical outcomes
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
Hazard ratio of clinical outcomes
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
Number of patients prescribed different treatments related to CKD and associated comorbidities
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
Describing cost associated with utilizing healthcare resources for CKD
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
Health related quality of life as assessed using the SF-36 questionnaire
Time frame: Prospective cohort: From baseline up to approximately 3 years
Physical activity as assessed using RAPA questionnaire
Time frame: Prospective cohort: From baseline up to approximately 3 years
Diet assessed using food dairies
Time frame: Prospective cohort: From baseline up to approximately 3 years
Work productivity as assessed WPAI
Time frame: Prospective cohort: From baseline up to approximately 3 years
Describing patient specific symptoms
Time frame: Prospective cohort: From baseline up to approximately 3 years
Describing patient experiences with CKD via qualitative interviews
Time frame: Prospective cohort: From baseline up to approximately 3 years
Number of deaths
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Derived from this study: PubMed 39611870Pollock 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.
- Derived from this study: PubMed 39173604Pollock C, Carrero JJ, Kanda E, Ofori-Asenso R, Palmer E, Niklasson A, Linder A, Woodward H, Pentakota S, Garcia Sanchez JJ, Kashihara N, Fishbane S, Pecoits-Filho R, Wheeler DC. The Lived Experience of Patients with Chronic Kidney Disease: Insights From DISCOVER CKD. Am J Nephrol. 2024;55(6):618-628. doi: 10.1159/000541064. Epub 2024 Aug 22.
- Derived from this study: PubMed 39052473Fishbane 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.
- Derived from this study: PubMed 38958839Heerspink 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.
- Derived from this study: PubMed 37578188Pollock 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.
- Derived from this study: PubMed 36090504James 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.
- Derived from this study: PubMed 35112306Pollock 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.
- CSR Synopsis\_RedactedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
43 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by AstraZeneca at 43 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Spain, Japan, United Kingdom, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Construct a cohort of patients with CKD (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04034992, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024; AzTrials last refreshed its copy on 26 Oct 2026.