A Prospecitve Multicenter, Observational Registry Study

Official title

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

Overview

This is a prospective, multicenter, observational registry study designed to collect data to deepen the understanding of CKD therapeutics, changes in clinical practice, cardiorenal risk outcomes and differences in treatment approaches in Chinese CKD patients.

Detailed description

To ensure a nationally representative cohort, a total of approximately 3000 participants will be enrolled from around 80 sites strategically selected from various geographic regions in China. The sites will include a mix of top-tier tertiary hospitals, regional medical centers, and representative secondary hospitals to accurately reflect real-world clinical practice at different levels of care. All enrolled participants will be followed up to 96 weeks according to the data collection schedule to assess long-term clinical outcomes. Investigators will obtain an informed consent from participants before screening. The CKD participants will only be considered enrolled in the study after providing written informed consent, followed by the assignment of a unique subject identifier. The data will be collected from medical records by the investigator and entered in a cloud-based electronic case report form (eCRF) using electronic data capture (EDC) system. The EDC system is a software tool designed to ensure quality assurance and facilitate data capture during the study. The data will be extracted from established medical records or other documents of the patients and transcribed to the EDC system.

Primary outcome measures

• Proportion of CKD patients with HP, HF, HTN, and HK at baseline, respectively [Time frame: baseline]
• Adoption rate of medications (e.g., Endothelin receptor antagonists [ERA], MRA, RASi, SGLT2i) [Time frame: Week 0 to week 96]
• Clinical indicators for CKD patients and CKD patients with HP, HF, HTN, or HK [Time frame: Week 0 to week 96]
• Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK [Time frame: Week 0 to week 96]
• Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK [Time frame: Week 0 to week 96]
• Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK [Time frame: Week 0 to week 96]
• Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK [Time frame: Week 0 to week 96]
• Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK [Time frame: Week 0 to week 96]
• Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK [Time frame: Week 0 to week 96]
• Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK [Time frame: Week 0 to week 96]

Secondary outcome measures (12)

• Clinical indicators of CKD patients and CKD patients with HP, HF, HTN, or HK [Time frame: Week 0 to week 96]
• The HCRU among patients with CKD overall, and in subgroups with HP, HF, HTN, or HK [Time frame: Week 0 to week 96]
• The factors associated with the clinical indicators in patients with CKD overall, and in subgroups [Time frame: Week 0 to week 96]
• Clinical outcomes of CKD patients and CKD patients with HP, HF, HTN, or HK [Time frame: Week 0 to week 96]
• Clinical indicators of CKD patients and CKD patients with HP, HF, HTN, or HK [Time frame: Week 0 to week 96]
• Clinical indicators of CKD patients and CKD patients with HP, HF, HTN, or HK [Time frame: Week 0 to week 96]
• Clinical indicators of CKD patients and CKD patients with HP, HF, HTN, or HK [Time frame: Week 0 to week 96]
• Clinical indicators of CKD patients and CKD patients with HP, HF, HTN, or HK [Time frame: Week 0 to week 96]
• Clinical indicators of CKD patients and CKD patients with HP, HF, HTN, or HK [Time frame: Week 0 to week 96]
• Clinical indicators of CKD patients and CKD patients with HP, HF, HTN, or HK [Time frame: Week 0 to week 96]
• Clinical indicators of CKD patients and CKD patients with HP and HTN [Time frame: Week 0 to week 96]
• Clinical indicators of CKD patients and CKD patients with HP and HTN [Time frame: Week 0 to week 96]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

China · 1 center

• Zhongshan Hospital Affilicated with Fudan University — Shanghai

Identifiers

NCT: NCT07481526 · D4327R00004

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗