A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Budoprutug (TNT119) in Subjects With Primary Membranous Nephropathy (PMN)
Status: Recruiting
Location: See all (45) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
To evaluate the safety and tolerability of three dose regimens of budoprutug in subjects with PMN
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
United States
Colorado
Climb Bio Investigative Site #110
RECRUITING
Denver
Florida
Climb Bio Investigative Site #105
RECRUITING
Orlando
Georgia
Climb Bio Investigative Site #108
RECRUITING
Atlanta
Indiana
Climb Bio Investigative Site #106
RECRUITING
Indianapolis
New York
Climb Bio Investigative Site #101
RECRUITING
Clifton Park
Pennsylvania
Climb Bio Investigative Site #102
NOT_YET_RECRUITING
Philadelphia
Texas
Climb Bio Investigative Site #103
RECRUITING
El Paso
Climb Bio Investigative Site #104
RECRUITING
Sherman
Other Locations
Argentina
Climb Bio Investigative Site# 602
RECRUITING
Buenos Aires
Climb Bio Investigative Site# 603
RECRUITING
Buenos Aires
Climb Bio Investigative Site #601
RECRUITING
Caba
Climb Bio Investigative Site #604
RECRUITING
Caba
Climb Bio Investigative Site #605
NOT_YET_RECRUITING
Córdoba
Climb Bio Investigative Site #606
RECRUITING
Santa Fe
Brazil
Climb Bio Investigative Site #502
RECRUITING
Belo Horizonte
Climb Bio Investigative Site #505
RECRUITING
Minas Gerais
Climb Bio Investigative Site #506
NOT_YET_RECRUITING
Pernambuco
Climb Bio Investigative Site #501
RECRUITING
Porto Alegre
Climb Bio Investigative Site #503
RECRUITING
São Paulo
Climb Bio Investigative Site #504
RECRUITING
São Paulo
Chile
Climb Bio Investigative Site #702
NOT_YET_RECRUITING
Santiago
Climb Bio Investigative Site #701
NOT_YET_RECRUITING
Temuco
Climb Bio Investigative Site #703
NOT_YET_RECRUITING
Valdivia
China
Climb Bio Investigative Site #401
NOT_YET_RECRUITING
Beijing
Climb Bio Investigative Site #403
NOT_YET_RECRUITING
Beijing
Climb Bio Investigative Site #406
NOT_YET_RECRUITING
Beijing
Climb Bio Investigative Site #405
NOT_YET_RECRUITING
Jinan
Climb Bio Investigative Site #408
NOT_YET_RECRUITING
Shenzhen
Climb Bio Investigative Site #402
NOT_YET_RECRUITING
Wuxi
Climb Bio Investigative Site #407
NOT_YET_RECRUITING
Xi'an
Climb Bio Investigative Site #409
NOT_YET_RECRUITING
Yantai
Climb Bio Investigative Site #404
NOT_YET_RECRUITING
Yibin
Georgia
Climb Bio Investigative Site #901
RECRUITING
Tbilisi
Climb Bio Investigative Site #902
RECRUITING
Tbilisi
Climb Bio Investigative Site #903
RECRUITING
Tbilisi
Taiwan
Climb Bio Investigative Site #204
RECRUITING
Taichung
Climb Bio Investigative Site #205
RECRUITING
Taipei
Climb Bio Investigative Site# 201
RECRUITING
Taipei
Climb Bio Investigative Site# 202
NOT_YET_RECRUITING
Taipei
Climb Bio Investigative Site# 203
NOT_YET_RECRUITING
Taipei
Ukraine
Climb Bio Investigative Site #803
RECRUITING
Ivano-frankivsk
Climb Bio Investigative Site #805
RECRUITING
Kyiv
Climb Bio Investigative Site# 801
RECRUITING
Kyiv
Climb Bio Investigative Site #804
RECRUITING
Rivne
Climb Bio Investigative Site #802
RECRUITING
Ternopil
Contact Information
Primary
Climb Bio Study Director
clinicaltrials@climbbio.com
+1 866 857 2596
Time Frame
Start Date: 2025-08-25
Estimated Completion Date: 2027-10
Participants
Target number of participants: 45
Treatments
Experimental: Cohort 1: Dose Level A
Experimental: Cohort 2: Dose Level B
Experimental: Cohort 3: Dose Level C
Related Therapeutic Areas
Sponsors
Leads: Climb Bio, Inc.