Budoprutug for primary membranous nephropathy (Phase 2)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Climb Bio Investigative Site #110
  Denver, Colorado, United States Recruiting
• Climb Bio Investigative Site #105
  Orlando, Florida, United States Recruiting
• Climb Bio Investigative Site #108
  Atlanta, Georgia, United States Recruiting
• Climb Bio Investigative Site #106
  Indianapolis, Indiana, United States Recruiting
• Climb Bio Investigative Site #101
  Clifton Park, New York, United States Recruiting
• Climb Bio Investigative Site #104
  Sherman, Texas, United States Recruiting

Study contacts

• Study coordinator: Climb Bio Study Director
• Email: clinicaltrials@climbbio.com
• Phone: +1 866 857 2596

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Surovatamig for adults with anti‑PLA2R primary membranous nephropathy

  This study will test whether subcutaneous surovatamig is safe and can reduce heavy proteinuria in adults with anti‑PLA2R–positive primary membranous nephropathy.

  Recruiting Phase 2 AstraZeneca · Los Angeles, California and 26 other locations · NCT07571746

• SHR-2173 injections for adults with primary membranous nephropathy

  This Phase II test will try SHR-2173 injections in adults (18–75) with biopsy-proven primary membranous nephropathy to see if they are safe, reduce disease activity, and to measure how the drug acts in the body.

  Recruiting Phase 2 Guangdong Hengrui Pharmaceutical Co., Ltd · Nanjing, Jiangsu · NCT07289763

• Povetacicept for people with primary membranous nephropathy

  This trial tests whether povetacicept is safe and helps people with primary membranous nephropathy, with tacrolimus listed as an intervention in the protocol.

  Recruiting at 116 sites Phase 2/3 Vertex Pharmaceuticals Incorporated · Montgomery, Alabama and 116 other locations · NCT07204275

• ALXN1920 for adults with primary membranous nephropathy

  This trial will test whether ALXN1920 reduces urine protein in adults with primary membranous nephropathy who are at high risk of progression compared with placebo.

  Recruiting at 35 sites Phase 2 Alexion Pharmaceuticals, Inc. · Loma Linda, California and 39 other locations · NCT07157787

• Evaluating YK012 for treating primary membranous nephropathy

  This study is testing a new treatment called YK012 to see if it can help people with primary membranous nephropathy feel better and how safe it is to use.

  Recruiting Phase 1 Excyte Biopharma Ltd · Beijing, Beijing Municipality · NCT06982729

• Felzartamab infusions for adults with primary membranous nephropathy

  This study tests whether felzartamab infusions help adults with primary membranous nephropathy reach complete remission of proteinuria compared with tacrolimus.

  Recruiting at 116 sites Phase 3 Biogen · Huntsville, Alabama and 116 other locations · NCT06962800

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.