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Registry platform for chronic kidney disease patients

Chronic Kidney Disease Registry Platform Study

AstraZeneca · NCT06117852

This study is collecting information from about 5,000 patients with chronic kidney disease in China to see how they are diagnosed and treated, and to find ways to improve their care.

Quick facts

Study typeObservational
Enrollment5000 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca (industry)
Drugs / interventionsPrednisone
Locations33 sites (Beijing and 32 other locations)
Trial IDNCT06117852 on ClinicalTrials.gov

What this trial studies

This multicenter, prospective, observational registry platform study aims to collect comprehensive data on demographics, clinical characteristics, diagnostic and treatment patterns, and outcomes of patients with chronic kidney disease (CKD) in China. The study will enroll approximately 5,000 high-risk CKD patients across at least 37 sites from 2023 to 2027. By establishing this registry, the study seeks to identify gaps in current CKD diagnosis and treatment guidelines, explore risk factors for disease progression, and develop predictive models for clinical outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who meet the diagnostic criteria for chronic kidney disease.

Not a fit: Patients who have undergone solid organ transplantation or have active malignant tumors requiring drug therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the understanding and management of chronic kidney disease, leading to better patient outcomes.

How similar studies have performed: Other studies have successfully established similar registries for chronic diseases, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Registry Platform Study Basic Inclusion \& Exclusion Criteria:

Inclusion Criteria:

1. Aged ≥ 18 years at enrollment;
2. Patients who meet the diagnostic criteria for CKD;
3. Last eGFR ≥ 20 and \< 90 mL/min/1.73 m2 (with the CKD-EPI formula) within 12 months prior to enrollment;
4. Patients who voluntarily participate in this study and has signed and dated the informed consent form for the study;

Exclusion Criteria:

1. Patients who have previously undergone/are undergoing/are planning to undergo solid organ transplantation;
2. Patients with active malignant tumor requiring drug therapy at the time of screening;
3. Women who are pregnant, planning to become pregnant or who are breastfeeding.

Group A (Participants with CKD and High Proteinuria) Inclusion \& Exclusion Criteria:

Inclusion criteria:

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.

Exclusion criteria:

1. Patients with NYHA class III or IV heart failure at screening;
2. 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;
3. Patients undergoing renal replacement therapy (RRT) at screening;
4. 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);
5. Patients with a life expectancy of less than 1 year, as judged by the investigator;
6. 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:

Inclusion criteria:

1. 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;
2. Patients with hypertension history and Systolic Blood Pressure ≥130 mmHg at screening;

Exclusion criteria:

1. Patients with NYHA class IV heart failure at screening;
2. 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;
3. Patients who have known severe hepatic injury (defined as Child-Pugh class C) based on medical history;
4. Patients undergoing renal replacement therapy (RRT) within 12 weeks prior to screening;
5. Patients on systemic immunosuppression prior to screening (inhalation, intranasal administration, or topical steroids are allowed) except for stable maintenance therapy at least 3 months;
6. Patients with a life expectancy of less than 1 year, as judged by the investigator;
7. Patients who have participated in another interventional clinical trial and have received the investigational drug within 1 months prior to being enrolled.

Where this trial is running

Beijing and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Chronic Kidney Diseases

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.