Overview

Telitacicept for PGNMID: A Single-Arm Study

Status:
ACTIVE_NOT_RECRUITING
Trial end date:
2027-05-29
Target enrollment:
Participant gender:
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 m) 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.
Phase:
PHASE2
Details
Lead Sponsor:
Peking University First Hospital
Treatments:
telitacicept