Prospective multicenter observational registry for chronic kidney disease in China

A Multicenter Real-World Registry of Characteristics, Treatment Strategies, and Clinical Outcomes in Chinese Adults With Chronic Kidney Disease

This registry will collect health and treatment data from adults with chronic kidney disease in China to see how therapies, clinical practice, and cardiorenal outcomes vary over time.

Quick facts

• Study type: Observational
• Enrollment: 3000 (estimated)
• Sex: All
• Sponsor: AstraZeneca (Industry-sponsored)
• Locations: 1 site (Shanghai)
• Trial ID: NCT07481526 on ClinicalTrials.gov

What this trial studies

Approximately 3,000 adults with chronic kidney disease will be enrolled from around 80 hospitals selected across different regions of China to create a nationally representative cohort. The registry is observational and non-interventional; participants will be followed for up to 96 weeks with data extracted from medical records and entered into a cloud-based electronic case report form using an EDC system. Participating sites include a mix of tertiary academic centers, regional medical centers, and representative secondary hospitals to reflect real-world practice at multiple levels of care. Investigators will obtain written informed consent and assign a unique subject identifier before enrollment, and inclusion/exclusion criteria (e.g., excluding ESRD on RRT, recent AKI, pregnancy, or life expectancy <2 years) will be applied.

Who should consider this trial

Good fit: Adults (≥18 years) in China with a confirmed diagnosis of CKD—such as eGFR <60 mL/min/1.73 m² for ≥3 months or persistent markers of kidney damage—who can provide written informed consent and are not on dialysis or enrolled in an interventional trial.

Not a fit: Patients with end-stage renal disease receiving dialysis or kidney replacement therapy, recent acute kidney injury, pregnant or breastfeeding women, those with life expectancy under two years, or individuals currently in interventional trials are excluded and would not benefit from participation.

Why it matters

Potential benefit: If successful, the registry could help clinicians in China improve CKD care by identifying real-world treatment patterns and risk factors linked to patient outcomes.

How similar studies have performed: Large CKD registries and observational cohorts internationally have successfully provided real-world evidence that informs guidelines and practice, so this approach is established rather than novel.

Eligibility criteria

Inclusion Criteria:

* Male or female patients aged ≥18 years.
* Willing and able to provide written informed consent to participate in the study.
* Confirmed CKD diagnosis at enrolment, defined by at least one of the following:

  * eGFR \<60 mL/min/1.73 m² for ≥3 months, OR
  * Evidence of kidney damage (e.g., UACR ≥30 mg/g or UPCR ≥150 mg/g, structural abnormality on imaging, or kidney biopsy findings consistent with chronic kidney injury) persisting for ≥3 months

Exclusion Criteria:

* Having a life-threatening comorbidity with life expectancy \< 2 years.
* Severe cardiac disease: life-threatening arrhythmias, or recent MACE (Myocardial infarction (MI), stroke, CV death) within the past 3 months.
* Pregnant or breastfeeding women.
* Currently enrolled in any interventional clinical trial or receiving investigational therapy within 3 months of enrollment.
* Presenting with ESRD, RRT, acute kidney injury (AKI), acute kidney disease (i.e., kidney injury or a decline in renal function persisting for ≤3 months) as a primary disease condition at enrollment.

Where this trial is running

Shanghai

• Zhongshan Hospital Affilicated with Fudan University — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Xiao Qiang Ding — Zhongshan Hospital Affiliated with Fudan University
• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions Chronic Kidney Disease