Chronic Kidney DiseasesNCT06117852
Chronic Kidney Disease Registry Platform Study
An observational study of Chronic Kidney Diseases, run by AstraZeneca at 34 sites in China.
Trial summary
This is a multicenter, prospective, observational registry platform study which is designed to establish a CKD registry platform by collecting data on the demographics, etiology and staging, clinical characteristics, diagnostic and treatment patterns, and clinical outcomes of patients with chronic kidney disease… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- How many people
- 5,000 participants
- Where
- 34 sitesChina
- Study dates
- 28 Nov 2023to 30 Nov 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CKD patients with age not less than 18 years old.
Who may be able to join
- Aged ≥ 18 years at enrollment;
- Patients who meet the diagnostic criteria for CKD;
- Last eGFR ≥ 20 and < 90 mL/min/1.73 m2 (with the CKD-EPI formula) within 12 months prior to enrollment;
- Patients who voluntarily participate in this study and has signed and dated the informed consent form for the study;
- Last documented proteinuria test within 12 months prior to enrollment indicating UACR ≥ 700 mg/g, or UPCR ≥ 1000 mg/g, or 24 h urine protein (quantitative) ≥ 1 g/24 h.
- Last documented test within 12 months prior to enrollment indicating UACR>200 mg/g（22.6 mg/mmol）and <5000 mg/g（565 mg/mmol）, or UPCR >500 mg/g and <8000 mg/g, or 24 h urine protein (quantitative) >0.5 g/24 h and <8 g/24 h;
- Patients with hypertension history and Systolic Blood Pressure ≥130 mmHg at screening;
Who cannot join
- Patients who have previously undergone/are undergoing/are planning to undergo solid organ transplantation;
- Patients with active malignant tumor requiring drug therapy at the time of screening;
- Women who are pregnant, planning to become pregnant or who are breastfeeding.
- Group A (Participants with CKD and High Proteinuria) Inclusion \& Exclusion Criteria:
- Patients with NYHA class III or IV heart failure at screening;
- Patients who have had myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), or undergone cardiac surgery, percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), valvular repair/replacement, or received treatment with left ventricular assist device within 3 months prior to screening;
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- Patients undergoing renal replacement therapy (RRT) at screening;
- Patients on systemic immunosuppression at screening (inhalation, intranasal administration, or topical steroids are allowed) except for stable maintenance therapy. The stable maintenance therapy means treatment at least 3 months with Prednisone 10mg/day or lower (or equivalent dose of other drugs), Azathioprine 100mg/day or lower, or Mycophenolate mofetil 1000mg/day or lower (or equivalent dose of other drugs);
- Patients with a life expectancy of less than 1 year, as judged by the investigator;
- Patients who have participated in another interventional clinical trial and have received the investigational drug within 1 month prior to being enrolled.
- Group B (patients with CKD and Hypertension) Inclusion \& Exclusion Criteria:
- Patients with NYHA class IV heart failure at screening;
- Patients who have had stroke, transient ischemic attack (TIA), Carotid artery surgery or carotid angioplasty and stenting, acute Coronary Syndrome, or hospitalization caused by heart failure deterioration within 3 months prior to screening;
- Patients who have known severe hepatic injury (defined as Child-Pugh class C) based on medical history;
- Patients undergoing renal replacement therapy (RRT) within 12 weeks prior to screening;
- Patients on systemic immunosuppression prior to screening (inhalation, intranasal administration, or topical steroids are allowed) except for stable maintenance therapy at least 3 months;
- Patients with a life expectancy of less than 1 year, as judged by the investigator;
- Patients who have participated in another interventional clinical trial and have received the investigational drug within 1 months prior to being enrolled.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
China34 sites
Research Site
Baotou
Research Site
Beijing
Research Site
Changsha
Research Site
Changzhou
Research Site
Chengdu
Research Site
Chongqing
Research Site
Dongguan
Research Site
Guangzhou
Research Site
Haikou
Research Site
Hefei
Research Site
Hengyang
Research Site
Huaian
Research Site
Jilin City
Research Site
Jining
Research Site
Nanchang
Research Site
Nanjing
Research Site
Nanning
Research Site
Ningbo
Research Site
Panjin
Research Site
Pingxiang
Research Site
Shanghai
Research Site
Shantou
Research Site
Shenzhen
Research Site
Taizhou
Research Site
Wenzhou
Research Site
Wuhan
Research Site
Wuxi
Research Site
Xiamen
Research Site
Xianyang
Research Site
Yantai
Research Site
Yibin
Research Site
Zhongshan
Research Site
Zhuzhou
Research Site
Zigong
About this study
This is a multicenter, prospective, observational registry platform study which is designed to establish a CKD registry platform by collecting data on the demographics, etiology and staging, clinical characteristics, diagnostic and treatment patterns, and clinical outcomes of patients with chronic kidney disease (CKD), to describe the current status of the diagnosis and treatment of patients with CKD and the gaps from the diagnostic and treatment guidelines, explore the risk factors for disease progression and clinical outcomes in CKD patients, and construct a risk prediction model for CKD progression and clinical outcomes
Read the detailed description
Chronic Kidney Disease (CKD) is characterized by its high prevalence, low awareness, poor prognosis, and high medical costs, which seriously jeopardize human health. High-risk factors such as severe proteinuria and uncontrolled hypertension further exacerbate the progression of CKD, leading to adverse kidney outcomes, cardiovascular diseases, hospitalizations, and increased mortality. Given these challenges, establishing a registry platform for high-risk CKD patients in China is essential.
This multicenter, prospective, observational registry study aims to comprehensively gather data on the demographic and clinical characteristics, diagnosis and treatment patterns, clinical outcomes, and healthcare resource utilization among high-risk CKD patients in China, which will facilitate the exploration of risk factors associated with CKD progression and clinical outcomes and support the development of predictive models for these outcomes. During the study period from 2023 to 2027, we plan to enroll approximately 5,000 Chinese CKD patients across at least 37 study sites. The study will establish different CKD subpopulations, including but not limited to CKD with High Proteinuria and CKD with Hypertension. Baseline data and annual follow-up data will be collected for the enrolled CKD patients. By establishing this CKD registry platform, we aim to describe the current status of the diagnosis and treatment of CKD patients, identify gaps from diagnostic and treatment guidelines, explore risk factors for disease progression and clinical outcomes, and construct risk prediction models for CKD progression and clinical outcomes.
- Conditions
- Chronic Kidney Diseases
- 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 |
|---|---|---|
| Group A | Participants with CKD and High Proteinuria | |
| Group B | Participants with CKD and Hypertension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Progression in CKD Patients
Patients with progressive deterioration of renal function, including decreased eGFR, rapid progression of CKD
Measured: From 2023 to 2027
Clinical Outcomes in CKD Patients - Renal Outcomes
Including renal transplantation, maintenance dialysis, death from renal failure, persistent low eGFR, persistent percent decline in eGFR
Measured: From 2023 to 2027
Clinical Outcomes in CKD Patients - Cardiovascular Outcomes
Including acute myocardial infarction, sudden serious arrhythmia, hospitalization due to heart failure, stroke or apoplexy, cardiovascular death
Measured: From 2023 to 2027
Clinical Outcomes in CKD Patients - Cardiac and Renal Composite Outcomes
Composite outcome measure consisting of multiple single outcome measures for cardiovascular outcomes and renal outcomes
Measured: From 2023 to 2027
Clinical Outcomes in CKD Patients - All-cause Mortality
In-hospital or out-of-hospital deaths from all causes, including but not limited to deaths related to cardiovascular outcomes or renal outcomes, etc.
Measured: From 2023 to 2027
Changes in Patient Conditions - Changes in Proteinuria
Changes in UACR, UPCR, and 24 h urine protein (quantitative) from baseline
Measured: From 2023 to 2027
Estimates of Changes in Patient Conditions - Changes in eGFR
Changes from baseline in glomerular filtration rate (eGFR), eGFR slope
Measured: From 2023 to 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start28 Nov 2023
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies 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
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bicheng Liu, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117852
- Sponsor's protocol ID
- D1843R00355
- Status last verified
- Aug 2026
- First submitted
- 31 Oct 2023
- Last updated
- 19 Aug 2026
- 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 Vivli.org. 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 approved.
Publications
Wang G, Bian X, Luo Q, Dong J, Chen W, Hao Y, Wang L, Xu G, Yi B, Liao X, Chen C, Niu J, Deng J, Chen L, Zhang Y, Zhou T, Li G, Zhang D, Li Y, Mao H, Lv J, Peng Q, Zhang C, Xiang P, Zhang J, Li H, Xiao Y, Liu B. C-INSIGHT: design and methodology of a nationwide registry for high-risk chronic kidney disease in China - a study protocol. BMC Nephrol. 2025 Oct 28;26(1):599. doi: 10.1186/s12882-025-04495-4.
PubMed 41152758
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Kidney Disease Registry Platform Study
- ClinicalTrials.gov ID
- NCT06117852
- Acronym / sponsor ID
- D1843R00355
- Conditions
- Chronic Kidney Diseases
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 7 Nov 2023 (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.
This is a multicenter, prospective, observational registry platform study which is designed to establish a CKD registry platform by collecting data on the demographics, etiology and staging, clinical characteristics, diagnostic and treatment patterns, and clinical outcomes of patients with chronic kidney disease (CKD), to describe the current status of the diagnosis and treatment of patients with CKD and the gaps from the diagnostic and treatment guidelines, explore the risk factors for disease progression and clinical outcomes in CKD patients, and construct a risk prediction model for CKD progression and clinical outcomes
Detailed description
Chronic Kidney Disease (CKD) is characterized by its high prevalence, low awareness, poor prognosis, and high medical costs, which seriously jeopardize human health. High-risk factors such as severe proteinuria and uncontrolled hypertension further exacerbate the progression of CKD, leading to adverse kidney outcomes, cardiovascular diseases, hospitalizations, and increased mortality. Given these challenges, establishing a registry platform for high-risk CKD patients in China is essential.
This multicenter, prospective, observational registry study aims to comprehensively gather data on the demographic and clinical characteristics, diagnosis and treatment patterns, clinical outcomes, and healthcare resource utilization among high-risk CKD patients in China, which will facilitate the exploration of risk factors associated with CKD progression and clinical outcomes and support the development of predictive models for these outcomes. During the study period from 2023 to 2027, we plan to enroll approximately 5,000 Chinese CKD patients across at least 37 study sites. The study will establish different CKD subpopulations, including but not limited to CKD with High Proteinuria and CKD with Hypertension. Baseline data and annual follow-up data will be collected for the enrolled CKD patients. By establishing this CKD registry platform, we aim to describe the current status of the diagnosis and treatment of CKD patients, identify gaps from diagnostic and treatment guidelines, explore risk factors for disease progression and clinical outcomes, and construct risk prediction models for CKD progression and clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Participants with CKD and High Proteinuria |
| Group B | – | –Participants with CKD and Hypertension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CKD patients with age not less than 18 years old.
Key inclusion criteria (7 listed)
- Aged ≥ 18 years at enrollment;
- Patients who meet the diagnostic criteria for CKD;
- Last eGFR ≥ 20 and < 90 mL/min/1.73 m2 (with the CKD-EPI formula) within 12 months prior to enrollment;
- Patients who voluntarily participate in this study and has signed and dated the informed consent form for the study;
- Last documented proteinuria test within 12 months prior to enrollment indicating UACR ≥ 700 mg/g, or UPCR ≥ 1000 mg/g, or 24 h urine protein (quantitative) ≥ 1 g/24 h.
Key exclusion criteria (18 listed)
- Patients who have previously undergone/are undergoing/are planning to undergo solid organ transplantation;
- Patients with active malignant tumor requiring drug therapy at the time of screening;
- Women who are pregnant, planning to become pregnant or who are breastfeeding.
- Patients with NYHA class III or IV heart failure at screening;
- Patients who have had myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), or undergone cardiac surgery, percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), valvular repair/replacement, or received treatment with left ventricular assist device within 3 months prior to screening;
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
Disease Progression in CKD Patients
Time frame: From 2023 to 2027
Patients with progressive deterioration of renal function, including decreased eGFR, rapid progression of CKD
Clinical Outcomes in CKD Patients - Renal Outcomes
Time frame: From 2023 to 2027
Including renal transplantation, maintenance dialysis, death from renal failure, persistent low eGFR, persistent percent decline in eGFR
Clinical Outcomes in CKD Patients - Cardiovascular Outcomes
Time frame: From 2023 to 2027
Including acute myocardial infarction, sudden serious arrhythmia, hospitalization due to heart failure, stroke or apoplexy, cardiovascular death
Clinical Outcomes in CKD Patients - Cardiac and Renal Composite Outcomes
Time frame: From 2023 to 2027
Composite outcome measure consisting of multiple single outcome measures for cardiovascular outcomes and renal outcomes
Clinical Outcomes in CKD Patients - All-cause Mortality
Time frame: From 2023 to 2027
In-hospital or out-of-hospital deaths from all causes, including but not limited to deaths related to cardiovascular outcomes or renal outcomes, etc.
Changes in Patient Conditions - Changes in Proteinuria
Time frame: From 2023 to 2027
Changes in UACR, UPCR, and 24 h urine protein (quantitative) from baseline
Estimates of Changes in Patient Conditions - Changes in eGFR
Time frame: From 2023 to 2027
Changes from baseline in glomerular filtration rate (eGFR), eGFR slope
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Derived from this study: PubMed 41152758Wang G, Bian X, Luo Q, Dong J, Chen W, Hao Y, Wang L, Xu G, Yi B, Liao X, Chen C, Niu J, Deng J, Chen L, Zhang Y, Zhou T, Li G, Zhang D, Li Y, Mao H, Lv J, Peng Q, Zhang C, Xiang P, Zhang J, Li H, Xiao Y, Liu B. C-INSIGHT: design and methodology of a nationwide registry for high-risk chronic kidney disease in China - a study protocol. BMC Nephrol. 2025 Oct 28;26(1):599. doi: 10.1186/s12882-025-04495-4.
- 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 Vivli.org. 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 approved.
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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.
Bicheng Liu principal investigator
Zhongda Hospital
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases, run by AstraZeneca at 34 sites in China.
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 7 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Disease Progression in CKD Patients (time frame: From 2023 to 2027). The study lists 7 primary outcomes in all. 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 NCT06117852, which also lists 1 linked publication.
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 19 Aug 2026.