Clinical Trials in the USA / NCT07096843
Recruiting
Phase 2
A Phase 2 Study of Budoprutug in Subjects With Primary Membranous Nephropathy
NCT07096843 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Primary Membranous Nephropathy
Investigational drug(s) / intervention(s)
budoprutug: Single IV dose of study product on Day 1, Day 15, Day 169 and Day 183
Study summary
To evaluate the safety and tolerability of three dose regimens of budoprutug in subjects with PMN
Eligibility
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
Primary outcome measure(s)
- Incidence of Treatment-Emergent Adverse Events (TEAEs) — Up to Week 48
Number of participants experiencing TEAEs, graded per NCI CTCAE v5.0.
Trial sites (38)
| Facility | City | Region | Status |
|---|---|---|---|
| Climb Bio Investigative Site #110 | Denver | Colorado | Recruiting |
| Climb Bio Investigative Site #105 | Orlando | Florida | Recruiting |
| Climb Bio Investigative Site #108 | Atlanta | Georgia | Recruiting |
| Climb Bio Investigative Site #106 | Indianapolis | Indiana | Recruiting |
| Climb Bio Investigative Site #101 | Clifton Park | New York | Recruiting |
| Climb Bio Investigative Site #104 | Sherman | Texas | Recruiting |
| Climb Bio Investigative Site# 602 | Buenos Aires | Argentina | Recruiting |
| Climb Bio Investigative Site# 603 | Buenos Aires | Argentina | Recruiting |
| Climb Bio Investigative Site #601 | CABA | Argentina | Recruiting |
| Climb Bio Investigative Site #604 | CABA | Argentina | Recruiting |
| Climb Bio Investigative Site #606 | Santa Fe | Argentina | Recruiting |
| Climb Bio Investigative Site #502 | Belo Horizonte | Brazil | Recruiting |
| Climb Bio Investigative Site #505 | Minas Gerais | Brazil | Recruiting |
| Climb Bio Investigative Site #506 | Pernambuco | Brazil | Recruiting |
| Climb Bio Investigative Site #501 | Porto Alegre | Brazil | Recruiting |
| Climb Bio Investigative Site #503 | São Paulo | Brazil | Recruiting |
| Climb Bio Investigative Site #504 | São Paulo | Brazil | Recruiting |
| Climb Bio Investigative Site #403 | Beijing | Changping District | Not Yet Recruiting |
| Climb Bio Investigative Site #401 | Beijing | Cheng District | Recruiting |
| Climb Bio Investigative Site #408 | Shenzhen | Guangdong | Not Yet Recruiting |
| Climb Bio Investigative Site #402 | Wuxi | Jiangsu | Recruiting |
| Climb Bio Investigative Site #405 | Jinan | Shandong | Not Yet Recruiting |
| Climb Bio Investigative Site #409 | Yantai | Shandong | Recruiting |
| Climb Bio Investigative Site #404 | Yibin | Sichuan | Recruiting |
| Climb Bio Investigative Site #406 | Beijing | Xicheng District | Recruiting |
| Climb Bio Investigative Site #903 | Tbilisi | Georgia | Recruiting |
| Climb Bio Investigative Site #902 | Tbilisi | Georgia | Recruiting |
| Climb Bio Investigative Site #901 | Tbilisi | Georgia | Recruiting |
| Climb Bio Investigative Site #204 | Taichung | Taiwan | Recruiting |
| Climb Bio Investigative Site# 202 | Taipei | Taiwan | Recruiting |
| Climb Bio Investigative Site# 201 | Taipei | Taiwan | Recruiting |
| Climb Bio Investigative Site #205 | Taipei | Taiwan | Recruiting |
| Climb Bio Investigative Site# 203 | Taipei | Taiwan | Recruiting |
| Climb Bio Investigative Site #803 | Ivano-Frankivsk | Ukraine | Recruiting |
| Climb Bio Investigative Site# 801 | Kyiv | Ukraine | Recruiting |
| Climb Bio Investigative Site #805 | Kyiv | Ukraine | Recruiting |
| Climb Bio Investigative Site #804 | Rivne | Ukraine | Recruiting |
| Climb Bio Investigative Site #802 | Ternopil | Ukraine | Recruiting |
More Climb Bio, Inc. trials in the USA
Other trials for the same condition
Official registry record
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.
View NCT07096843 on ClinicalTrials.gov ↗ ← All trials in the USA