Telitacicept for PGNMID: A Single-Arm Study (NCT07111338) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Telitacicept for PGNMID: A Single-Arm Study
China10 participantsStarted 2025-07-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years
✓. Renal biopsy consistent with proliferative glomerulonephritis with monoclonal immunoglobulin deposits (PGNMID) confirmed by central pathologic review
✓. 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)
✓. Estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73 m² calculated by CKD-EPI equation
✓. Willing and able to provide written informed consent and comply with all study procedures
Exclusion criteria
✕. Rapidly progressive glomerulonephritis or crescentic disease (\>50 % crescents)
✕. Known malignant hematologic disorders (e.g., multiple myeloma, lymphoma)
✕. Active malignancy (except adequately treated basal-cell carcinoma) within 5 years