- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03001934
Super Chinese Nephrotic Syndrome Registration System (SUCCESS)
October 20, 2020 updated by: Xue Qing Yu, Sun Yat-sen University
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.
Study Overview
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 Type
Observational
Enrollment (Anticipated)
5000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Naya Huang, M.D. & Ph.D
- Email: huangnaya@163.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510080
- Recruiting
- The 1st Affiliated Hospital, Sun Yet-sen University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Nephrotic syndrome patients
Description
Inclusion Criteria:
- Nephrotic syndrome patients regardless of the primary causes
Exclusion Criteria:
- No
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Nephrotic syndrome patients
Patients diagnosis as nephrotic syndrome (NS)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The patient survival in NS patients
Time Frame: 10 years
|
10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Renal survival in NS patients
Time Frame: 10 years
|
Renal survival including end stage renal disease, dialysis, renal transplantation
|
10 years
|
Longitudinal changes of renal function of NS patients
Time Frame: 10 years
|
10 years
|
|
Treatment response of NS patients
Time Frame: 10 years
|
10 years
|
|
Infection rate of NS patients
Time Frame: 10 years
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2016
Primary Completion (ANTICIPATED)
December 1, 2026
Study Completion (ANTICIPATED)
December 1, 2028
Study Registration Dates
First Submitted
December 21, 2016
First Submitted That Met QC Criteria
December 21, 2016
First Posted (ESTIMATE)
December 23, 2016
Study Record Updates
Last Update Posted (ACTUAL)
October 22, 2020
Last Update Submitted That Met QC Criteria
October 20, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SUCCESS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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