ClinicalTrials.gg
RecruitingNCT03001947Updated Sep 15, 2026

IgA Nephropathy Registration Initiative of High Quality (INSIGHT)

An observational study in IgA Nephropathy, sponsored by Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Sun Yat-sen University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,000
Ages
14 Years and older
Sex
All
01

Study 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.

Read the detailed description

The investigators are registering all biopsy-proven primary IgA nephropathy (IgAN) patients, and developing a IgAN database 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 ESRD, and lab measurements of serum and urine), complications, drug information at the baseline will be collected. Patients will be follow-up every one year, the demographic and clinical characteristics, complications and drug information of patients will be collected at each visit. The investigators also record the clinical events at each visit, such as mortality (including all-cause mortality and cardiovascular disease mortality), ESRD (defined as initiation of dialysis or kidney transplantation) and hospitalization for any cause. All-cause and cardiovascular mortality and a composite renal outcome of doubling of serum creatinine and ESRD for IgAN patients will be compared using the IgAN database.

02

Conditions studied

  • IgA Nephropathy

Keywords

  • IgA nephropathy
  • All-cause mortality
  • Cardiovascular mortality
  • A composite renal outcome
03

In context

Glomerulonephritis, IGA

275 studies on the registry are indexed under Glomerulonephritis, IGA; 107 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 245 across 45 observational studies indexed under Glomerulonephritis, IGA.

Browse Glomerulonephritis, IGA studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,690 studies on the registry; 619 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Biopsy-proven primary IgAN patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. -proven primary IgAN patients;
  2. age ≥14 years old
  3. Adequate biopsy sample containing ≥8 glomeruli.

Exclusion criteria

Exclusion Criteria:

Secondary causes of mesangial IgA deposition, such as Henoch-Schonlein purpura nephritis, systemic lupus erythematosus, liver cirrhosis and et al; ≤15ml/min/1.73m2 at .

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • IgAN patients

    Biopsy-proven primary IgAN patients

    Other: No intervention

Interventions

  • OtherNo intervention

    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.

06

What researchers measure

Primary outcomes

  1. All-cause and cardiovascular mortality of IgAN patients

    Time frame: 10 years

  2. 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).

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2012, a primary completion of Dec 2029 and a completion of Dec 2029. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 21, 2016
First posted
Dec 23, 2016
Start
Nov 2012
Primary completionEst.
Dec 2029
CompletionEst.
Dec 2029
Last update
Sep 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03001947
Responsible party
Xue Qing Yu (Professor, Sun Yat-sen University) — Principal investigator
First posted
Dec 23, 2016
Start date
Nov 2012
Primary completion
Dec 2029 (estimated)
Completion
Dec 2029 (estimated)
Last update
Sep 15, 2026

Study contacts

Xueqing Yu, M.D. & Ph.D
Contact
yuxq@mail.sysu.edu.cn
Qiongqiong Yang, M.D. & Ph.D
Contact
qiongqyzzm@qq.com
8620-87755766 ext. 843

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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