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

NCT04438603 | Unknown

• 1 other identifier: XHEC-C-2020-070-1
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

IgA Nephropathy

Keywords

IgA Nephropathy; IR-Seq; Biomarker

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 24-hour urine protein level

  24 weeks

• Serum albumin level

  24 weeks

• eGFR (estimated using the 2009 CKD-EPI formula)

  24 weeks

Study Arms (5)

IgAN patients at low risk of disease progression

n = 30, incipient disease

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

IgAN patients at high risk of disease progression

n = 60, incipient disease

Drug: Intervention for patients at high risk of disease progression

Long-term stable patients

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

Progressive IgAN patients

n = 30

Healthy control

n = 30

Interventions

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

Intervention for patients at high risk of disease progression 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.

IgAN patients at high risk of disease progression

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, RenJi Hospital, Shanghai Zhongshan Hospital, Longhua Hospital Shanghai University of Traditional Chinese Medicine and Shanghai East Hospital

You may qualify if:

• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead
• RenJi Hospital: collaborator
• Shanghai Zhongshan Hospital: collaborator
• Shanghai University of Traditional Chinese Medicine: collaborator

Study Sites (1)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum samples; Blood samples taken using PAXgene vacuum blood collection tubes

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

Methods

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 19, 2020
• Study Start: October 1, 2020
• Primary Completion: March 31, 2022
• Study Completion: September 30, 2022
• Last Updated: August 28, 2020

Record last verified: 2020-08

Locations

CN (1)