Home › Trials › NCT07096843

Budoprutug for primary membranous nephropathy (Phase 2)

A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Budoprutug (TNT119) in Subjects With Primary Membranous Nephropathy (PMN)

Phase 2 Interventional Climb Bio, Inc. · NCT07096843

This trial will test whether budoprutug, an anti-CD19 antibody given by IV, is safe and tolerated and may reduce proteinuria in adults with PLA2R-positive primary membranous nephropathy who still have high protein in their urine despite RAAS blockers.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment45 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorClimb Bio, Inc. Industry-sponsored
Locations45 sites (Denver, Colorado and 44 other locations)
Trial IDNCT07096843 on ClinicalTrials.gov

What this trial studies

This is a Phase 2, open-label, multicenter study that enrolls about 45 adults with PLA2R-positive primary membranous nephropathy and persistent proteinuria despite optimized RAAS inhibition. Participants are assigned to three sequential dose cohorts and receive four IV administrations of budoprutug on Days 1, 15, 169 and 183. The study monitors safety, pharmacodynamics (including B-cell depletion), and preliminary signals of efficacy through Week 48, with extended follow-up as needed for B-cell recovery. The trial excludes people with secondary causes of membranous nephropathy, recent B-cell depletion, active high-risk infections, or other major contraindications.

Who should consider this trial

Good fit: Ideal candidates are adults with confirmed PLA2R-positive primary membranous nephropathy who have UPCR ≥2.0 g/g, eGFR ≥35 mL/min/1.73 m², CD19+ B cell count ≥40 cells/μL, and are on stable RAAS inhibitor therapy with controlled blood pressure.

Not a fit: Patients with secondary membranous nephropathy, recent B-cell–depleting therapy, active or high-risk infections, pregnancy or breastfeeding, very low kidney function, or recent major surgery are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, budoprutug could offer another B-cell–targeted option that lowers proteinuria and helps preserve kidney function in PLA2R-positive PMN patients.

How similar studies have performed: B-cell depletion with anti-CD20 agents like rituximab has shown benefit in PMN, while anti-CD19 therapies such as budoprutug are a newer approach with limited clinical data in this disease.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Denver, Colorado and 44 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Primary Membranous NephropathyPMNAnti-CD19PrisMN
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.