The Applicaiton of Immune Repertoire in the Diagnosis and Disease Monitoring of IgA Nephropathy

• Conditions: IgA Nephropathy
• Interventions: Drug: Intervention for incipient patients at low risk of disease progression; Drug: Intervention for patients at high risk of disease progression

• Registration Number: NCT04438603
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Study Timeline

• Study First Submitted: 2020-06-17
• Study First Submitted QC: 2020-06-18
• Study First Posted: 2020-06-19
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-26
• Last Update Posted: 2020-08-28
• Study Start: 2020-10-01
• Primary Completion: 2022-03-31
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. IgA nephropathy:

2. Age: 18-80 years.

3. Patients diagnosed with primary IgA nephropathy by renal biopsy.

4. Estimated glomerular filtration rate (using the 2009 CKD-EPI formula) ≥30ml/min/1.73/m^2.

5. Obtain informed consent from patients. 2. Healthy Control: Gender, age and ethnicity matched health volunteers. 3. IgAN patients were further divided into 4 groups, as defined below:

1. Long-term stable patients:

Follow-up for at least 15 years and meet at least one of the following:

1. Annual eGFR loss rate <3ml/min/1.73m^2.
2. eGFR>90ml/min/1.73m^2. 2) Non-progressive IgAN patients:

Meet at least one of the following:

1. eGFR decrease of more than 50% from baseline (in the absence of other possible causes of kidney damage).
2. Annual eGFR loss rate >5ml/min/1.73m^2.
3. Progress to ESRD. 3) IgAN patients at low risk of disease progression: Proteinuria ≤ 1g/24h after 3 months of optimized supportive care. 4) IgAN patients at high risk of disease progression: Proteinuria > 1g/24h despite 3 months of optimized supportive care.

Exclusion Criteria

1. Kidney biopsy shows crescentic IgAN or MCD-IgAN.;
2. Patients with secondary IgAN;
3. During pregnancy or lactation;
4. After kidney transplantation;
5. More than one serious acute infection in the psat 12 months;
6. Chronic infection;
7. Use of glucocorticosteroids and other immunosuppressive drugs within the last 6 months;
8. Incomplete medical history or clinical data.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IgAN patients at low risk of disease progression	Intervention for incipient patients at low risk of disease progression	n = 30, incipient disease
IgAN patients at high risk of disease progression	Intervention for patients at high risk of disease progression	n = 60, incipient disease

Primary Outcome Measures

Name	Time	Method
Urinary protein remission rate	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 Outcome Measures

Name	Time	Method
24-hour urine protein level	24 weeks
Serum albumin level	24 weeks
eGFR (estimated using the 2009 CKD-EPI formula)	24 weeks

Trial Locations

Locations (1)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China