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

Shanghai Jiao Tong University

Status: Unknown

Conditions: IgA Nephropathy

Treatments: Drug: Intervention for incipient patients at low risk of disease progression; Drug: Intervention for patients at high risk of disease progression

Study type: Observational

Funder types: Other

Identifiers

NCT04438603

XHEC-C-2020-070-1

Details and patient eligibility

About

This prospective study aims to investigate the role of IR-Seq in the diagnosis and disease monitoring in patients with IgA nephropathy.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

180 participants in 5 patient groups

IgAN patients at low risk of disease progression

Description:

n = 30, incipient disease

Treatment:

Drug: Intervention for incipient patients at low risk of disease progression

IgAN patients at high risk of disease progression

Description:

n = 60, incipient disease

Treatment:

Drug: Intervention for patients at high risk of disease progression

Long-term stable patients

Description:

n = 30, follow-up for at least 15 years

Progressive IgAN patients

Description:

n = 30

Healthy control

Description:

n = 30