NCT05863936

Trial of Belimumab Combined With Multi-target Induction Therapy in Lupus Nephritis

Clinical Trial of Belimumab Combined With Multi-target Induction Therapy in Adult Patients With Severe Lupus Nephritis

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Nanjing University School of Medicine · Academic / Other
• Sex: All
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this single-center, prospective clinical trial is to test the safety and efficacy of belimumab combined with multi-target therapy in the treatment of severe lupus nephritis. The main questions it aims to answer are: lupus nephritis complete remission rate at week 24, and the partial remission rate and safety assessments. Patients with severe lupus nephritis will be enrolled and received pulse methylprednisolone at a dose of 1.5 to 3.0g, followed by intravenous belimumab at a dose of 10mg per kilogram at weeks 2, 4, and 6, and every 4 weeks thereafter. Multitarget therapy will be also administered during the induction phase. Induction therapy will last for 24 weeks. Patients with severe lupus nephritis who only received multi-target therapy during the same period will be enrolled as the control group.

Conditions

• Lupus Nephritis
• Remission
• Safety Issues

Interventions

Type	Name	Description
DRUG	Methylprednisolone Injectable Suspension	Methylprednisolone pulse therapy, total dose from 1500mg to 3000mg.
DRUG	Belimumab Injection	Belimumab at a dose of 10mg per kilogram at weeks 2, 4, and 6, and every 4 weeks for 24 weeks.
DRUG	Immunosuppressive Agents	1. Mycophenolate Mofetil, oral, 1.0-1.5g per day; 2. Tacrolimus, oral, 2-4mg per day.

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-03-31
• Completion: 2024-12-31
• First posted: 2023-05-18
• Last updated: 2023-05-18

Locations

1 site across 1 country: China