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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05188885
• Other study ID #: GDPH-CKD-MIP-01
• Status: Recruiting
• Start date: December 27, 2021
• Est. completion date: December 27, 2028

Study information

• Verified date: February 2023
• Source: Guangdong Provincial People's Hospital
• Contact: Xueqing Yu, MD
• Phone: +86-20-83827812
• Email: yuxueqing[@]gdph.org.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90000
• Est. completion date: December 27, 2028
• Est. primary completion date: December 27, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The occurrence and development of complications of chronic renal disease	Renal anemia, renal hypertension, mineral bone metabolism disorders, etc.	up to 5 years
Other	Rate of Participants with cardiovascular events.	Rate of Participants with cardiovascular events.	up to 5 years
Other	Rate of Participants with cerebrovascular events.	Rate of Participants with cerebrovascular events.	up to 5 years
Other	All causes mortality	All causes mortality.	up to 5 years
Other	Rate of Participants with hospitalization.	Rate of Participants with hospitalization.	up to 5 years
Other	Changes in cognitive function score.	Changes in cognitive function score by questionnaire.	up to 5 years
Other	Rate of Participants with new-onset diabetes	Rate of Participants with new-onset diabetes.	up to 5 years
Other	Rate of Participants with severe infection	Rate of Participants with infections that need intravenous injections or hospitalization.	up to 5 years
Other	Rate of Participants with bone fracture	Rate of Participants with bone fracture.	up to 5 years
Other	Rate of Participants with tumor	Rate of Participants with tumors.	up to 5 years
Other	Rate of Participants with malnutrition	A decrease of body weight more than 15%, and/or serum albumin decreased to less than 30 g/L.	up to 5 years
Other	Rate of Participants with pregnancy	Rate of Participants with pregnancy and birth	up to 5 years
Primary	The occurrence of chronic kidney diseases in non-CKD participants	The occurrence of chronic kidney disease is defined by KDIGO (Kidney Disease: Improving Global Outcomes) in 2012.	up to 5 years
Primary	The progression of chronic kidney diseases in CKD participants	The progression of chronic kidney disease is defined as: Patients with baseline estimated glomerular filtration rate (eGFR) =60 ml /min/1.73m2 had an eGFR decrease of 30% or more, and decreased to <60 ml /min/1.73m2; Or a 50% or greater decrease in baseline eGFR <60 ml /min/1.73m2; Or end-stage renal disease (eGFR <15 ml /min/1.73m2, or initiation of renal replacement therapy)	up to 5 years
Secondary	Progression in albuminuria	Progression in albuminuria: Patients with baseline urinary albumin to creatinine Ratio (uACR) <30 mg/g had uACR doubled and increased to =30 mg/g; or patients with baseline uACR <300 mg/g had a doubling of uACR and an increase to =300 mg/g.	up to 5 years
Secondary	New onset of albuminuria	Onset of albuminuria: Patients with baseline uACR <30 mg/g increased to =30 mg/g.	up to 5 years
Secondary	New onset of macroalbuminuria	Onset of macroalbuminuria: Patients with baseline uACR <300 mg/g increased to =300 mg/g.	up to 5 years
Secondary	Composite endpoints of progression of chronic kidney disease and progression of albuminuria	Composite endpoints of progression of chronic kidney disease and progression of albuminuria.	up to 5 years
Secondary	Composite endpoint of progression of chronic kidney disease, progression of albuminuria, and all-cause death.	Composite endpoint of progression of chronic kidney disease, progression of albuminuria, and all-cause death.	up to 5 years
Secondary	Change of estimated eGFR	Change rate per year.	up to 5 years
Secondary	change of uACR	Change rate per year.	up to 5 years
Secondary	Rapid decrease of renal function	The annual decrease rate of eGFR was > 5mL/min/1.73m2.	up to 5 years