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ACTIVE NOT RECRUITING
NCT07111338
PHASE2

Telitacicept for PGNMID: A Single-Arm Study

Sponsor: Peking University First Hospital

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.

Official title: Telitacicept in the Treatment of Proliferative Glomerulonephritis With Monoclonal Immunoglobulin Deposits (PGNMID): A Prospective, Single-Arm Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-07-12

Completion Date

2027-05-29

Last Updated

2025-08-08

Healthy Volunteers

No

Interventions

DRUG

Telitacicept 160mg

Telitacicept (RC18) is a recombinant TACI-Fc fusion protein that simultaneously neutralizes B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), thereby inhibiting B-cell differentiation and plasma-cell survival. In this study, it is supplied as a sterile, preservative-free, lyophilized powder (160 mg/vial) that is reconstituted with 1 mL water for injection and administered subcutaneously into the abdomen or thigh at a fixed dose of 160 mg once weekly for 24 weeks. Each injection is performed by trained study personnel, and pre-filled backup syringes are available to ensure exact dosing. No dose escalation or tapering is planned; dose reductions or temporary discontinuation are allowed only for predefined safety criteria.

Locations (1)

Peking University First Hospital, Renal Division

Beijing, Beijing Municipality, China