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

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT04438603

Collaborator

RenJi Hospital (Other), Shanghai Zhongshan Hospital (Other), Shanghai University of Traditional Chinese Medicine (Other)

180

Enrollment

Location

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
IgA Nephropathy	Drug: Intervention for incipient patients at low risk of disease progression Drug: Intervention for patients at high risk of disease progression

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 Design

Study Type:

Observational

Anticipated Enrollment :

180 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Mar 31, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
IgAN patients at low risk of disease progression n = 30, incipient disease	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
IgAN patients at high risk of disease progression n = 60, incipient disease	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: 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.
Long-term stable patients n = 30, follow-up for at least 15 years
Progressive IgAN patients n = 30
Healthy control n = 30

Outcome Measures

Primary Outcome Measures

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

24-hour urine protein level [24 weeks]
Serum albumin level [24 weeks]
eGFR (estimated using the 2009 CKD-EPI formula) [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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:

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 Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai		China

Sponsors and Collaborators

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
RenJi Hospital
Shanghai Zhongshan Hospital
Shanghai University of Traditional Chinese Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

ClinicalTrials.gov Identifier:

NCT04438603

Other Study ID Numbers:

XHEC-C-2020-070-1

First Posted:

Jun 19, 2020

Last Update Posted:

Aug 28, 2020

Last Verified:

Aug 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

IgA Nephropathy

IR-Seq

Biomarker

Additional relevant MeSH terms:

Kidney Diseases

Glomerulonephritis, IGA

Study Results

No Results Posted as of Aug 28, 2020