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

NCT ID: NCT04438603

Last Updated: 2020-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2022-09-30

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.

Conditions

IgA Nephropathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

IgAN patients at low risk of disease progression

n = 30, incipient disease

Intervention for incipient patients at low risk of disease progression

Intervention Type: DRUG

Conservative treatment, if necessary use ACEI/ARB and titrated to the maximum tolerated dose, with a BP-lowering goal of \< 130/80 mm Hg

IgAN patients at high risk of disease progression

n = 60, incipient disease

Intervention for patients at high risk of disease progression

Intervention Type: DRUG

BP-lowering goal of < 125/75 mm Hg and treat with steroids or steroids combined with immunosuppressants based on optimal supportive therapy:

1. 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.

2. 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.

Long-term stable patients

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

No interventions assigned to this group

Progressive IgAN patients

n = 30

No interventions assigned to this group

Healthy control

n = 30

No interventions assigned to this group

Interventions

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 Type: DRUG

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:

1. 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.

2. 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

RenJi Hospital

OTHER

Sponsor Role: collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: collaborator

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Jiang Gengru

Role: primary

jianggeng-ru@hotmail.com

+86-13917983703

Other Identifiers

XHEC-C-2020-070-1

Identifier Type: -

Identifier Source: org_study_id