NCT04438603

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 180 (estimated)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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
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.

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-03-31
• Completion: 2022-09-30
• First posted: 2020-06-19
• Last updated: 2020-08-28

Locations

1 site across 1 country: China