Super Chinese Nephrotic Syndrome Registration System (SUCCESS)

Nephrotic Syndrome Clinical Trial

Official title:

Super Chinese Nephrotic Syndrome Registration System (SUCCESS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03001934
• Other study ID #: SUCCESS
• Status: Recruiting
• Start date: April 2016
• Est. completion date: December 2028

Study information

• Verified date: October 2020
• Source: Sun Yat-sen University
• Contact: Xueqing Yu, M.D. & Ph.D
• Email: yuxq[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The investigators are registering all nephrotic syndrome (NS) patients regardless of the primary causes and developing a NS database in China. Patients will be followed-up and both baseline and follow-up information will be recorded in the registration system. The treatment response, longitudinal changes of renal function, renal survival, patient survival, infection events and acute kidney injury etc, will be analyzed using the NS database.

Description:

The investigators are registering all NS patients regardless of the primary causes in China. Patients' demographic characteristics (including age, gender, height, weight, BMI, smoking, drinking, and education), clinical characteristics (including systolic blood pressure, diastolic blood pressure, primary cause of NS, and lab measurements of serum, urine), pathological characteristics, treatment and treatment response, complications and outcomes. Patients will be followed up, the demographic, clinical characteristics, treatment, lab tests of blood and urine and complications of patients will be collected and recorded at each visit. The investigators also record the outcome at each visit, such as treatment response, longitudinal changes of renal function, hospitalization, occurrence of infection or cardiovascular events etc. The outcomes will be analyzed using the NS database.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 2028
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

• Nephrotic syndrome patients regardless of the primary causes

Exclusion Criteria:

• No

Related Conditions & MeSH terms

• Nephrosis
• Nephrotic Syndrome
• Syndrome

Intervention

Other:
• No intervention
Registration of all NS patients in the First Affiliated Hospital of Sun Yat-sen University and other hospitals which have signed the contract in China.

Locations

Country	Name	City	State
China	The 1st Affiliated Hospital, Sun Yet-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The patient survival in NS patients		10 years
Secondary	Renal survival in NS patients	Renal survival including end stage renal disease, dialysis, renal transplantation	10 years
Secondary	Longitudinal changes of renal function of NS patients		10 years
Secondary	Treatment response of NS patients		10 years
Secondary	Infection rate of NS patients		10 years