Chronic Kidney Disease Registry Platform Study
1 other identifier
observational
5,000
1 country
34
Brief 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 (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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2023
Longer than P75 for all trials
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2023
CompletedFirst Posted
Study publicly available on registry
November 7, 2023
CompletedStudy Start
First participant enrolled
November 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2028
May 5, 2026
April 1, 2026
5 years
October 31, 2023
May 4, 2026
Conditions
Outcome Measures
Primary Outcomes (7)
Disease Progression in CKD Patients
Patients with progressive deterioration of renal function, including decreased eGFR, rapid progression of CKD
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
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
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
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.
From 2023 to 2027
Changes in Patient Conditions - Changes in Proteinuria
Changes in UACR, UPCR, and 24 h urine protein (quantitative) from baseline
From 2023 to 2027
Estimates of Changes in Patient Conditions - Changes in eGFR
Changes from baseline in glomerular filtration rate (eGFR), eGFR slope
From 2023 to 2027
Study Arms (2)
Group A
Participants with CKD and High Proteinuria
Group B
Participants with CKD and Hypertension
Eligibility Criteria
CKD patients with age not less than 18 years old.
You may not qualify if:
- 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;
- 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.
- 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.
- 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;
- 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.
- 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;
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (34)
Research Site
Baotou, China
Research Site
Beijing, China
Research Site
Changsha, China
Research Site
Changzhou, China
Research Site
Chengdu, China
Research Site
Chongqing, China
Research Site
Dongguan, China
Research Site
Guangzhou, China
Research Site
Haikou, China
Research Site
Hefei, China
Research Site
Hengyang, China
Research Site
Huaian, China
Research Site
Jilin, China
Research Site
Jining, China
Research Site
Nanchang, China
Research Site
Nanjing, China
Research Site
Nanning, China
Research Site
Ningbo, China
Research Site
Panjin, China
Research Site
Pingxiang, China
Research Site
Shanghai, China
Research Site
Shantou, China
Research Site
Shenzhen, China
Research Site
Taizhou, China
Research Site
Wenzhou, China
Research Site
Wuhan, China
Research Site
Wuxi, China
Research Site
Xiamen, China
Research Site
Xianyang, China
Research Site
Yantai, China
Research Site
Yibin, China
Research Site
Zhongshan, China
Research Site
Zhuzhou, China
Research Site
Zigong, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bicheng Liu
Zhongda Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2023
First Posted
November 7, 2023
Study Start
November 28, 2023
Primary Completion (Estimated)
November 30, 2028
Study Completion (Estimated)
November 30, 2028
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- 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.
- Access Criteria
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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.