NCT03001934

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
30mo left

Started Apr 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Apr 2016Dec 2028

Study Start

First participant enrolled

April 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2016

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

10.7 years

First QC Date

December 21, 2016

Last Update Submit

October 20, 2020

Conditions

Nephrotic Syndrome

Keywords

Nephrotic syndromeTreatment responseRenal function

Outcome Measures

Primary Outcomes (1)

  • The patient survival in NS patients

    10 years

Secondary Outcomes (4)

  • Renal survival in NS patients

    10 years

  • Longitudinal changes of renal function of NS patients

    10 years

  • Treatment response of NS patients

    10 years

  • Infection rate of NS patients

    10 years

Study Arms (1)

Nephrotic syndrome patients

Patients diagnosis as nephrotic syndrome (NS)

Other: No intervention

Interventions

No interventionOTHER

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.

Nephrotic syndrome patients

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Nephrotic syndrome patients

You may qualify if:

  • Nephrotic syndrome patients regardless of the primary causes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The 1st Affiliated Hospital, Sun Yet-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The serum, urine, DNA and renal tissue will be collected.

MeSH Terms

Conditions

Nephrotic Syndrome

Condition Hierarchy (Ancestors)

NephrosisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Xueqing Yu, M.D. & Ph.D

CONTACT

yuxq@mail.sysu.edu.cn

Naya Huang, M.D. & Ph.D

CONTACT

huangnaya@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 21, 2016

First Posted

December 23, 2016

Study Start

April 1, 2016

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2028

Last Updated

October 22, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share

Locations

CN(1)