Telitacicept for PGNMID: A Single-Arm Study

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

July 12, 2025

Primary Completion Date

May 29, 2027

Study Completion Date

May 29, 2027

Conditions
Proliferative Glomerulonephritis With Monoclonal Immunoglobulin Deposits
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.

Trial Locations (1)

100034

Peking University First Hospital, Renal Division, Beijing

All Listed Sponsors
lead

Peking University First Hospital

OTHER

NCT07111338 - Telitacicept for PGNMID: A Single-Arm Study | Biotech Hunter | Biotech Hunter