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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Eligibility Criteria
\*\*Inclusion Criteria\*\*
1. Age ≥ 18 years
2. Renal biopsy consistent with proliferative glomerulonephritis with monoclonal immunoglobulin deposits (PGNMID) confirmed by central pathologic review
3. 24-hour urine protein ≥ 1 g on two occasions ≥ 4 weeks apart while receiving optimal renin-angiotensin system blockade (ACEi or ARB at maximal tolerated dose)
4. Estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73 m² calculated by CKD-EPI equation
5. Willing and able to provide written informed consent and comply with all study procedures
\*\*Exclusion Criteria\*\*
1. Rapidly progressive glomerulonephritis or crescentic disease (\>50 % crescents)
2. Known malignant hematologic disorders (e.g., multiple myeloma, lymphoma)
3. Active malignancy (except adequately treated basal-cell carcinoma) within 5 years
4. Neutrophil count \< 1.0 × 10⁹/L, hemoglobin \< 80 g/L, or platelet count \< 50 × 10⁹/L
5. ALT or AST \> 2.5 × upper limit of normal (ULN) or total bilirubin \> 1.5 × ULN
6. Chronic obstructive pulmonary disease (COPD) requiring systemic steroids or Stage III/IV heart failure (NYHA)
7. Systemic immunosuppressive or biologic therapy (e.g., cyclophosphamide, rituximab, bortezomib, lenalidomide, tacrolimus, mycophenolate, etc.) within 3 months prior to screening
8. Chronic or latent infection: active tuberculosis, HBV (HBsAg-positive or HBV-DNA-positive), HCV antibody-positive, or HIV-positive
9. Live vaccine within 4 weeks of screening
10. Known hypersensitivity to telitacicept or any excipients
11. Pregnancy, breastfeeding, or inadequate contraception (women of child-bearing potential and men not using highly effective contraception)
12. Any condition that, in the investigator's opinion, would compromise participant safety or interfere with study conduct
Primary outcome measure(s)
Change in 24-hour urine protein excretion from baseline to Week 24 — Baseline (Week 0) to Week 24 Absolute change (g/24 h) in quantitative proteinuria from baseline (Week 0) to Week 24 after the first telitacicept dose, measured by 24-hour urine collection and averaged from two consecutive collections obtained within 7 days of the target visit.
Trial sites (1)
Facility
City
Region
Status
Peking University First Hospital, Renal Division
Beijing
Beijing Municipality
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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