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A single-arm, single-center clinical study of rituximab therapy in AAGN-induced remission

A single-arm, single-center clinical study of rituximab therapy in AAGN-induced remission

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050955
Enrollment
Unknown
Registered
2021-09-08
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ANCA-associated glomerulonephritis

Interventions

Experimental group:Rituximab therapy during induction of AAGN

Sponsors

Pediatric Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of granulomatosis with polyangiitis (GPA) (EULAR/PRINTO/PRES, 2008 classification criteria) and microscopic polyangiitis (MPA) (Chapel Hill consensus meeting, 2012) . 2. Aged 2-18 years, no gender limit. 3. Patients with newly diagnosed AAGN who meet the following definitions: (1) Evidence of kidney damage: 24-hour urine protein>0.3g/d, or urine protein/creatinine > 0.3, or microscopic red blood cells > 5/HP, or pathologically confirmed AAGN necrotizing pauci-immune complex glomerulonephritis; (2) Pediatric Vasculitis Activity Score (PVAS) in children is greater than or equal to 3 points, and the disease is severe enough to warrant the use of CYC; (3) Positive for PR3-ANCA or MPO-ANCA at screening. 4. Mandatory prophylactic treatment for Pneumocystis jirovecii infection is mandatory for all eligible participants. 5. The legal guardian of the subject fully knows and signs the informed consent, and the subject can cooperate to complete the follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients requiring mechanical ventilation due to alveolar hemorrhage. 2. There is a history of anti-glomerular basement membrane disease (anti-GBM). 3. Active systemic infection. 4. Deep infection such as osteomyelitis, septic arthritis or pneumonia complicated by thoracic abscess or lung abscess within 6 months before entering the study. 5. Active infectious disease: history of HIV, syphilis, tuberculosis, hepatitis B or hepatitis C infection. 6. Acute or chronic liver disease. 7. Have any known malignancy, or a history of malignancy in any organ system within the past 5 years. 8. Other uncontrolled diseases. 9. Pregnancy or lactation.

Design outcomes

Primary

MeasureTime frame
urine protein;kidney function;blood pressure;pediatric vasculitis activity score;

Countries

China

Contacts

Public ContactSun Li

Pediatric Hospital Affiliated to Fudan University

lillysun@263.net+86 18017749990

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026