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New treatment option for Primary Membranous Nephropathy
Official title A Phase 2 Study of Budoprutug in Subjects With Primary Membranous Nephropathy
ClinicalTrials.gov ID: NCT07096843
What this study is testing
What is budoprutug?
budoprutug is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for primary membranous nephropathy.
Also referred to as TNT119.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the safety and tolerability of three dose regimens of budoprutug in subjects with PMN
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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 may apply
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Indianapolis, Indiana, United States
- Boston, Massachusetts, United States
- Clifton Park, New York, United States
- Sherman, Texas, United States
- Buenos Aires, Argentina
- CABA, Argentina
- Santa Fe, Argentina
- Belo Horizonte, Brazil
- Minas Gerais, Brazil
- Pernambuco, Brazil
- Porto Alegre, Brazil
- São Paulo, Brazil
- Temuco, Araucania, Chile
- Valdivia, Los Ríos Region, Chile
- Santiago, Santiago Metropolitan, Chile
- Beijing, Changping District, China
- Beijing, Cheng District, China
+ 14 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, United States; Orlando, Florida, United States; Atlanta, Georgia, United States; Indianapolis, Indiana, United States; Boston, Massachusetts, United States; Clifton Park, New York, United States and 28 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.