Super Chinese Nephrotic Syndrome Registration System (SUCCESS)

• Sponsor: Sun Yat-sen University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03001934
• Collaborator: (none)
• Enrollment: 5,000
• Location: 1
• Duration (Months): 152
• Patients Per Site Per Month: 32.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Nephrotic Syndrome	Other: No intervention

Detailed 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.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 5000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Super Chinese Nephrotic Syndrome Registration System (SUCCESS)
• Study Start Date: Apr 1, 2016
• Anticipated Primary Completion Date: Dec 1, 2026
• Anticipated Study Completion Date: Dec 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Nephrotic syndrome patients Patients diagnosis as nephrotic syndrome (NS)	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.

Outcome Measures

Primary Outcome Measures

1. The patient survival in NS patients [10 years]

Secondary Outcome Measures

1. Renal survival in NS patients [10 years]

   Renal survival including end stage renal disease, dialysis, renal transplantation

2. Longitudinal changes of renal function of NS patients [10 years]

3. Treatment response of NS patients [10 years]

4. Infection rate of NS patients [10 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Nephrotic syndrome patients regardless of the primary causes

Exclusion Criteria:

• No

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The 1st Affiliated Hospital, Sun Yet-sen University	Guangzhou	Guangdong	China	510080

Sponsors and Collaborators

• Sun Yat-sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xue Qing Yu, Professor, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT03001934
• Other Study ID Numbers: SUCCESS
• First Posted: Dec 23, 2016
• Last Update Posted: Oct 22, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Xue Qing Yu, Professor, Sun Yat-sen University: Nephrotic syndrome; Treatment response; Renal function
• Additional relevant MeSH terms: Nephrotic Syndrome; Nephrosis; Syndrome

Study Results

No Results Posted as of Oct 22, 2020