Status:
UNKNOWN
The Applicaiton of Immune Repertoire in the Diagnosis and Disease Monitoring of IgA Nephropathy
Lead Sponsor:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborating Sponsors:
RenJi Hospital
Shanghai Zhongshan Hospital
Conditions:
IgA Nephropathy
Eligibility:
All Genders
18-80 years
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) ...
Eligibility Criteria
Inclusion
- 1\. 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\^2.
- 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:
- Annual eGFR loss rate \<3ml/min/1.73m\^2.
- eGFR\>90ml/min/1.73m\^2. 2) Non-progressive IgAN patients:
- Meet at least one of the following:
- eGFR decrease of more than 50% from baseline (in the absence of other possible causes of kidney damage).
- Annual eGFR loss rate \>5ml/min/1.73m\^2.
- 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
- 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.
Key Trial Info
Start Date :
October 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2022
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04438603
Start Date
October 1 2020
End Date
September 30 2022
Last Update
August 28 2020
Active Locations (1)
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1
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China