Skip to content

A national multicenter clinical study of podocyte autoantibodies predicting the recurrence of INS patients within one year

Preliminary exploration of the diagnosis and treatment plan for autoimmune podocyte disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300076577
Enrollment
Unknown
Registered
2023-10-12
Start date
2022-10-01
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic nephrotic syndrome

Interventions

Gold Standard:Patients with remission or recurrence of INS after treatment: recurrence of 24-hour urine protein>50mg/kg, or urine protein/creatinine>2000mg/kg. In children, recurrence is usually evalu
Index test:The levels of podocyte autoantibodies (Vinculin auto Ab, Serine argenine-rich slicing factor 9 auto-Ab, Proteasome subunit alpha type-1 auto-Ab, Aconate hydratase 2 auto-Ab, Peptidyl-propyl

Sponsors

The Children's Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 18 Years

Inclusion criteria

Inclusion criteria: Idiopathic nephrotic syndrome patients with complete remission of disease aged 2-18 years.

Exclusion criteria

Exclusion criteria: (1) Other kidney diseases, such as hereditary kidney disease, purpura nephritis, reflux nephropathy, diabetic nephropathy, amyloidosis, hypertensive nephropathy, etc. ; (2) Other autoimmune diseases, such as systemic lupus erythematosus, idiopathic arthritis, and ANCA-related vasculitis. ; (3) Subjects cannot observe or endure the necessary inspection procedures; (4) Patients with major mental illness or disturbance of consciousness, which researchers believe will have an impact on patient treatment and follow-up; (5) Patients who the researcher thought were not suitable for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
Vinculin auto-Ab;Serine arginine-rich splicing factor 9 auto-Ab;Proteasome subunit alpha type-1 auto-Ab;Aconitate hydratase 2 auto-Ab;Peptidyl-prolyl cis-trans isomerase D auto-Ab;Pcroxircdoxin 1 auto-Ab;F-actin-capping protein subunit beta auto-Ab;Recurrence after remission;Area under ROC curve;Accuracy;Sensitivity;Specificity;Positive predictive value;Negative predictive value;

Countries

China

Contacts

Public ContactQing Ye

The Children's Hospital, Zhejiang University School of Medicine

qingye@zju.edu.cn+86 135 7576 1052

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026