The Applicaiton of Immune Repertoire in the Diagnosis and Disease Monitoring of IgA Nephropathy
Overview
- Phase
- Not Applicable
- Intervention
- Intervention for incipient patients at low risk of disease progression
- Conditions
- IgA Nephropathy
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Urinary protein remission rate
- Last Updated
- 5 years ago
Overview
Brief Summary
This prospective study aims to investigate the role of IR-Seq in the diagnosis and disease monitoring in patients with IgA nephropathy.
Detailed Description
Autoimmunity may play an important role in IgA nephropathy, and previous studies have shown that immune repertoire sequencing (IR-Seq) may help elucidate the dynamic changes of immune repertoire (IR) in autoimmune disease states. To further explore the potential application value of this technology, we will conduct a series of prospective studies to investigate the role of IR-Seq in the diagnosis and disease monitoring in patients with IgA nephropathy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •IgA nephropathy:
- •Age: 18-80 years.
- •Patients diagnosed with primary IgA nephropathy by renal biopsy.
- •Estimated glomerular filtration rate (using the 2009 CKD-EPI formula) ≥30ml/min/1.73/m\^
- •Obtain informed consent from patients.
- •Healthy Control: Gender, age and ethnicity matched health volunteers.
- •IgAN patients were further divided into 4 groups, as defined below:
- •Long-term stable patients:
- •Follow-up for at least 15 years and meet at least one of the following:
- •Annual eGFR loss rate \<3ml/min/1.73m\^
Exclusion Criteria
- •Kidney biopsy shows crescentic IgAN or MCD-IgAN.;
- •Patients with secondary IgAN;
- •During pregnancy or lactation;
- •After kidney transplantation;
- •More than one serious acute infection in the psat 12 months;
- •Chronic infection;
- •Use of glucocorticosteroids and other immunosuppressive drugs within the last 6 months;
- •Incomplete medical history or clinical data.
Arms & Interventions
IgAN patients at low risk of disease progression
n = 30, incipient disease
Intervention: Intervention for incipient patients at low risk of disease progression
IgAN patients at high risk of disease progression
n = 60, incipient disease
Intervention: Intervention for patients at high risk of disease progression
Outcomes
Primary Outcomes
Urinary protein remission rate
Time Frame: 24 weeks
Including complete and partial remission rate of urinary protein. Complete remission criteria: post-treatment urine protein \<0.3 g/24h; partial remission criteria: post-treatment urine protein \<50% of the maximum value.
Secondary Outcomes
- eGFR (estimated using the 2009 CKD-EPI formula)(24 weeks)
- 24-hour urine protein level(24 weeks)
- Serum albumin level(24 weeks)