Telitacicept for PGNMID: A Single-Arm Study

Summary

This single-center, prospective, single-arm study will evaluate the efficacy and safety of telitacicept in 10 adults with biopsy-proven proliferative glomerulonephritis with monoclonal immunoglobulin deposits (PGNMID). Eligible participants (≥18 y, ≥1 g/day proteinuria, eGFR ≥20 mL/min/1.73 m²) will receive 160 mg telitacicept subcutaneously once weekly for 24 weeks after a 12-week run-in on maximally tolerated ACEi/ARB. The primary endpoint is change in 24-hour urine protein from baseline to Week 24. Secondary endpoints include changes in eGFR, urine red-blood-cell count, and serum immunoglobulin/complement levels. Safety will be monitored throughout. Recruitment is planned from May 2025 to May 2027 at Peking University First Hospital.

Timeline

Start

2025-07-12

Primary completion

2027-05-29

Completion

2027-05-29

Drugs

Indications