A Phase 2 Study of Budoprutug in Subjects With Primary Membranous Nephropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: budoprutug.
- Who it may be relevant to
- Registry conditions: Primary Membranous Nephropathy. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Brazil, Chile, China +3
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Budoprutug (TNT119) in Subjects With Primary Membranous Nephropathy (PMN)
Overview
To evaluate the safety and tolerability of three dose regimens of budoprutug in subjects with PMN
Detailed description
Budoprutug is a humanized, immunoglobulin (Ig) G1 monoclonal antibody that selectively binds to CD19 and is projected to deplete targeted cells through antibody-dependent cellular cytotoxicity (ADCC). This Phase 2, open-label, multicenter study evaluates the safety, pharmacodynamics, and preliminary efficacy of three intravenous dose regimens of budoprutug in adult subjects with primary membranous nephropathy (PMN) who are anti-PLA2R antibody positive and have persistent proteinuria despite optimized RAAS inhibition. Approximately 45 subjects will be enrolled across three sequential dose cohorts, each receiving a single IV dose of budoprutug on Day 1, Day 15, Day 169 and Day 183. Subjects will be followed through Week 48, with extended follow-up for B-cell recovery as needed.
Interventions
- Drug budoprutug
Single IV dose of study product on Day 1, Day 15, Day 169 and Day 183
Primary outcome measures
- Incidence of Treatment-Emergent Adverse Events (TEAEs) [Time frame: Up to Week 48]
Secondary outcome measures (12)
- Change in total B Cell Count [Time frame: Up to Week 48]
- Change in Anti-PLA2R Antibodies [Time frame: Up to Week 48]
- Complete Remission Rate [Time frame: Week 48]
- Complete or Partial Remission Rate [Time frame: Week 48]
- Change in Proteinuria [Time frame: Up to Week 48]
- Change in UACR [Time frame: Up to Week 48]
- Change in eGFR [Time frame: Up to Week 48]
- Area Under the Curve (AUC) [Time frame: Up to Week 48]
- Maximum Observed Plasma Concentration (Cmax) [Time frame: Up to Week 48]
- Time to Maximum Observed Concentration (Tmax) [Time frame: Up to Week 48]
- Terminal Half-Life (T1/2) [Time frame: Up to Week 48]
- Apparent Clearance (CL/F) [Time frame: Up to Week 48]
Eligibility criteria
Inclusion criteria
- Confirmed diagnosis of PMN with positive anti-PLA2R antibodies
- CD19+ B cell count ≥40 cells/μL
- UPCR ≥2.0 g/g
- eGFR ≥35 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)
- Other inclusion criteria may apply
Exclusion criteria
- 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
- Other exclusion criteria may apply
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 9 centers
- Climb Bio Investigative Site #403 — Beijing
- Climb Bio Investigative Site #401 — Beijing
- Climb Bio Investigative Site #408 — Shenzhen
- Climb Bio Investigative Site #402 — Wuxi
- Climb Bio Investigative Site #407 — Xi'an
- Climb Bio Investigative Site #405 — Jinan
- Climb Bio Investigative Site #409 — Yantai
- Climb Bio Investigative Site #404 — Yibin
- … and 1 more center
United States · 7 centers
- Climb Bio Investigative Site #110 — Denver
- Climb Bio Investigative Site #105 — Orlando
- Climb Bio Investigative Site #108 — Atlanta
- Climb Bio Investigative Site #106 — Indianapolis
- Climb Bio Investigative Site #111 — Boston
- Climb Bio Investigative Site #101 — Clifton Park
- Climb Bio Investigative Site #104 — Sherman
Brazil · 6 centers
- Climb Bio Investigative Site #502 — Belo Horizonte
- Climb Bio Investigative Site #505 — Minas Gerais
- Climb Bio Investigative Site #506 — Pernambuco
- Climb Bio Investigative Site #501 — Porto Alegre
- Climb Bio Investigative Site #503 — São Paulo
- Climb Bio Investigative Site #504 — São Paulo
Argentina · 5 centers
- Climb Bio Investigative Site# 602 — Buenos Aires
- Climb Bio Investigative Site# 603 — Buenos Aires
- Climb Bio Investigative Site #601 — CABA
- Climb Bio Investigative Site #604 — CABA
- Climb Bio Investigative Site #606 — Santa Fe
Taiwan · 5 centers
- Climb Bio Investigative Site #204 — Taichung
- Climb Bio Investigative Site# 202 — Taipei
- Climb Bio Investigative Site# 201 — Taipei
- Climb Bio Investigative Site #205 — Taipei
- Climb Bio Investigative Site# 203 — Taipei
Ukraine · 5 centers
- Climb Bio Investigative Site #803 — Ivano-Frankivsk
- Climb Bio Investigative Site# 801 — Kyiv
- Climb Bio Investigative Site #805 — Kyiv
- Climb Bio Investigative Site #804 — Rivne
- Climb Bio Investigative Site #802 — Ternopil
Chile · 3 centers
- Climb Bio Investigative Site #701 — Temuco
- Climb Bio Investigative Site #703 — Valdivia
- Climb Bio Investigative Site #702 — Santiago
Georgia · 3 centers
- Climb Bio Investigative Site #903 — Tbilisi
- Climb Bio Investigative Site #902 — Tbilisi
- Climb Bio Investigative Site #901 — Tbilisi
Identifiers
NCT: NCT07096843 · TNT119-PMN-201