IgA Nephropathy Registration Initiative of High Quality (INSIGHT)
1 other identifier
observational
10,000
1 country
1
Brief Summary
The investigators are registering all biopsy-proven primary IgA nephropathy (IgAN) patients at recruited hospitals and developing a IgAN database in China. Patients will be follow-up every one year, and both baseline and follow-up information will be entered into the registration system. All-cause and cardiovascular mortality and a composite renal outcome of doubling of serum creatinine and end stage renal failure (ESRD, defined as initiation of dialysis or kidney transplantation) of IgAN patients will be compared using the IgAN database.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 21, 2016
CompletedFirst Posted
Study publicly available on registry
December 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
October 22, 2020
October 1, 2020
14.1 years
December 21, 2016
October 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
All-cause and cardiovascular mortality of IgAN patients
10 years
A composite renal outcome of IgAN patients
The composite renal outcome defined as doubling of serum creatinine and ESRD (defined as initiation of dialysis or kidney transplantation).
10 years
Study Arms (1)
IgAN patients
Biopsy-proven primary IgAN patients
Interventions
Registration of all IgAN patients in the First Affiliated Hospital of Sun Yat-sen University and other hospitals which have signed the contract in China.
Eligibility Criteria
Biopsy-proven primary IgAN patients
You may qualify if:
- Biopsy-proven primary IgAN patients;
- age ≥14 years old
- Adequate biopsy sample containing ≥8 glomeruli.
You may not qualify if:
- Secondary causes of mesangial IgA deposition, such as Henoch-Schonlein purpura nephritis, systemic lupus erythematosus, liver cirrhosis and et al; eGFR≤15ml/min/1.73m2 at biopsy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510080, China
Biospecimen
The serum, urine, DNA and renal tissue will be collected.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
November 1, 2012
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
October 22, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will share