Telitacicept for PGNMID: A Single-Arm Study

Conditions

• Proliferative Glomerulonephritis With Monoclonal Immunoglobulin Deposits

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Telitacicept 160mg — DRUG
  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.

Study Details

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.

Key Dates

Start date

Jul 12, 2025

Status verified

Feb 2025

Primary completion

May 29, 2027

Completion

May 29, 2027

Study Design

Enrollment

10 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Telitacicept 160 mg Subcutaneous Once Weekly
  Participants receive telitacicept 160 mg by subcutaneous injection once weekly for 24 consecutive weeks. No placebo or active comparator is provided.

Primary Outcome Measure

Change in 24-hour urine protein excretion from baseline to Week 24 [ Time Frame: Baseline (Week 0) to Week 24 ]