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

IgA Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04438603
• Other study ID #: XHEC-C-2020-070-1
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: August 2020
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: September 30, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. IgA nephropathy:

1. Age: 18-80 years.

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

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

4. 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.

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases

Intervention

Drug:
• Intervention for incipient patients at low risk of disease progression
Conservative treatment, if necessary use ACEI/ARB and titrated to the maximum tolerated dose, with a BP-lowering goal of < 130/80 mm Hg
• Intervention for patients at high risk of disease progression
BP-lowering goal of < 125/75 mm Hg and treat with steroids or steroids combined with immunosuppressants based on optimal supportive therapy: If GFR>60 ml/min/1.73m^2, oral prednisone 0.6-0.8 mg/kg/day ( (maximum dose 48 mg/day) for 2 months, followed by a monthly dose reduction of 8 mg for 24 weeks. If GFR is 30-60 ml/min/1.73m^2, intravenous cyclophosphamide (CTX) 750 mg per month per m^2 for 6 months, along with oral prednisone (at the same dose as 1); if intravenous administration is unacceptable, then the above regimen was replaced with oral mycophenolate mofetil 500 mg bid for 24 weeks.

Locations

Country	Name	City	State
China	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Longhua Hospital Shanghai University of Traditional Chinese Medicine, RenJi Hospital, Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary protein remission rate	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.	24 weeks
Secondary	24-hour urine protein level		24 weeks
Secondary	Serum albumin level		24 weeks
Secondary	eGFR (estimated using the 2009 CKD-EPI formula)		24 weeks