A Real World, Multi-centric, Observational Registry Study of Chronic Kidney Diseases

Overview

Chronic kidney disease (CKD) refers to a variety of different diseases characterized by impairment of kidney structure and/or renal function. The prevalence of CKD in China is as high as 10.8%. With a population of more than 150 million, China has the largest number of CKD patients all over the world. People with CKD would not only progress to uremia and need renal replace treatment, it also significantly increases risk of cardiovascular disease than non-CKD population. It has created a heavy burden on people's health and national economy. There is an urgent need to establish an effective system for CKD prevention and control in China. Evidences from large sample cohort and real world based research are still rare. This study will provide good experience for reducing the occurrence and development of CKD.

Detailed description

This study is designed as an investigator-initiated, multi-center, prospective and observational real world study based on mainland Chinese population. The investigators aimed to investigate the occurrence, development, treatment, prognosis state and related risk factors of CKD in China.

This study based on the standardized data network, which provides efficient data collection, integration and analysis for researchers and clinicians in multi-centers.

The sample size of this study was estimated by statisticians, epidemiologists and clinicians. Real-world studies adopted an open standard for inclusion and exclusion, larger sample size could cover a wider group of patients and take the possibility of loss of follow-up into account. Subgroup analysis can be performed in a heterogeneous population and expand the significance of the study.

Primary outcome measures

• The occurrence of chronic kidney diseases in non-CKD participants [Time frame: up to 5 years]
• The progression of chronic kidney diseases in CKD participants [Time frame: up to 5 years]

Secondary outcome measures (8)

• Progression in albuminuria [Time frame: up to 5 years]
• New onset of albuminuria [Time frame: up to 5 years]
• New onset of macroalbuminuria [Time frame: up to 5 years]
• Composite endpoints of progression of chronic kidney disease and progression of albuminuria [Time frame: up to 5 years]
• Composite endpoint of progression of chronic kidney disease, progression of albuminuria, and all-cause death. [Time frame: up to 5 years]
• Change of estimated eGFR [Time frame: up to 5 years]
• change of uACR [Time frame: up to 5 years]
• Rapid decrease of renal function [Time frame: up to 5 years]

Eligibility criteria

Inclusion criteria

• Patients diagnosed with CKD as defined in the KDIGO Clinical Practice Guidelines for the Evaluation and Management of Chronic Kidney Disease 2012 Edition;
• Non-CKD patients with hypertension, diabetes, hyperlipidemia, hyperuricemia, eGFR (CKD-EPI formula) of 60-89 ml/min/1.73m\^2 and other risk factors for CKD;
• Healthy population.
• Signed the informed consent voluntarily.

Exclusion criteria

。Patients identified to be unsuitable for enrollment by the study physician.

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

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

China · 8 centers

• The Second People's Hospital of Nanhai District in Foshan City — Foshan
• Guangdong Provincial Peoples Hospital — Guangzhou
• The First Affiliated Hospital of Sun Yat-sen University — Guangzhou
• Wuhua County People's Hospital — Meizhou
• Fogang County People's Hospital — Qingyuan
• People's Hospital of Yingde — Qingyuan
• Zhuhai Golden Bay Central Hospital — Zhuhai
• Ganzhou Municipal Hospital — Ganzhou

Identifiers

NCT: NCT05188885 · GDPH-CKD-MIP-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗