RecruitingPhase 2NCT07096843
A Phase 2 Study of Budoprutug in Subjects With Primary Membranous Nephropathy
A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Budoprutug (TNT119) in Subjects With Primary Membranous Nephropathy (PMN)
Sponsor
Climb Bio, Inc.
Enrollment
45 participants
Start Date
Aug 25, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
To evaluate the safety and tolerability of three dose regimens of budoprutug in subjects with PMN
Eligibility
Min Age: 18 YearsMax Age: 70 Years
Inclusion Criteria8
- Confirmed diagnosis of PMN with positive anti-PLA2R antibodies
- CD19+ B cell count ≥40 cells/μL
- UPCR ≥2.0 g/g
- eGFR ≥40 mL/min/1.73 m²
- Stable RAAS inhibitor therapy
- Blood pressure \<150/90 mmHg at baseline
- Adequate hematologic, hepatic, and renal function
- Willing to use effective contraception (both sexes)
Exclusion Criteria8
- Secondary Membranous Nephropathy
- Rapidly progressive glomerulonephritis or other glomerulopathies
- Prior B cell-depleting therapy within 24 weeks
- Recent use of immunosuppressants
- Active or high-risk infections
- History of malignancy
- Pregnancy or breastfeeding
- Recent major surgery or hospitalization
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Interventions
DRUGbudoprutug
Single IV dose of study product on Day 1, Day 15, Day 169 and Day 183
Locations(33)
View Full Details on ClinicalTrials.gov
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NCT07096843
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