Clinical Trial

Telitacicept for PGNMID: A Single-Arm Study

Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
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.
Trial Details
NCT Number NCT07111338
Lead Sponsor Peking University First Hospital
Conditions Proliferative Glomerulonephritis With Monoclonal Immunoglobulin Deposits
Enrollment 10 participants
Start Date 2025-07-12
Primary Completion 2027-05-29 (estimated)
Study Completion 2027-05-29 (estimated)
Updated on ClinicalTrials.gov 2025-08-08