NCT06786338

A Study of SGB-9768 in Patients with Complement-mediated Kidney Diseases

A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of SGB-9768 in Patients with Primary IgA Nephropathy, C3 Glomerulopathy, and Immune Complex-mediated Membranoproliferative Glomerulonephritis.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Suzhou Sanegene Bio Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study looks at how well and safely SGB-9768 works for patients with certain kidney diseases: primary IgA nephropathy, C3 glomerulopathy, and immune complex-related membranoproliferative glomerulonephritis. It's a phase 2 trial done at several locations where both patients and doctors know what treatment is being given.

Detailed description

This is a phase 2, multicenter, open-label study to evaluate of the efficacy and safety of SGB-9768 in patients with primary IgA nephropathy, C3 glomerulopathy, and immune complex-mediated membranoproliferative glomerulonephritis. The primary objective is to evaluate efficacy of SGB-9768 in reducing urine protein excretion and maintain kidney function in these patients. Secondly, safety, pharmacokinetics and pharmacodynamics will be charaterized.

Conditions

• IgA Nephropathy (IgAN)
• C3 Glomerulopathy
• IC-MPGN

Interventions

Type	Name	Description
DRUG	SGB-9768	SGB-9768 for subcutaneous (SC) injection

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-07-01
• Completion: 2026-10-01
• First posted: 2025-01-22
• Last updated: 2025-01-22

Locations

11 sites across 1 country: China