Kidney Week

Abstract: INFO15-SA

PODOMOUNT-pFSGS: Design of a Phase 3 Trial of TRPC6 Inhibitor Apecotrep in Adults and Adolescents with Primary or Genetic FSGS

Session Information

• Informational Posters - 3
  October 24, 2026 | Location: Exhibit Hall A, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Glomerular Diseases

• No subcategory defined

Authors

• Pinter, Jule, Department of Nephrology, University Clinic Hamburg-Eppendorf, Hamburg, Germany

Jule Pinter, MD, MSc

• Mariani, Laura H., University of Michigan, Ann Arbor, Michigan, United States

Laura H. Mariani, MD, MS, FASN

• Gale, Daniel P., Department of Renal Medicine, University College London, London, United Kingdom

Daniel P. Gale, MD, PhD

• Steubl, Dominik, Boehringer Ingelheim, Ingelheim am Rhein, Germany

Dominik Steubl, MD

• Licariao Rocha, Fabia Tais, Boehringer Ingelheim, Ingelheim am Rhein, Germany

Fabia Tais Licariao Rocha, MD

• Sun, Zhichao, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, United States

Zhichao Sun, PhD

• Zhao, Minghui, Renal Division, Peking University First Hospital, Beijing, China

Minghui Zhao, PhD

• Trachtman, Howard, University of Michigan, Ann Arbor, Michigan, United States

Howard Trachtman, MD, FASN

• Hosseini-Tabatabaei, Azadeh, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, United States

Azadeh Hosseini-Tabatabaei

Description

Focal segmental glomerulosclerosis (FSGS) results from podocyte damage, which often presents with high proteinuria. Inhibition of transient receptor potential cation channel, subfamily C, member 6 (TRPC6), a calcium channel expressed on podocytes, is a novel podocyte-targeted therapeutic approach for FSGS. In a Phase II trial, oral TRPC6 inhibitor apecotrep 20 mg resulted in a placebo-corrected 40% reduction from baseline to Week 12 in 24-hour urinary protein-to-creatinine ratio (UPCR), and was well tolerated with a favourable safety profile in patients with primary FSGS (pFSGS) or genetic FSGS resulting from TRPC6 gain-of-function (GoF) variants.

PODOMOUNT-pFSGS (NCT07220083) is a Phase III, global, multicentre, randomized, double-blind, placebo-controlled trial investigating the efficacy and safety of apecotrep in proteinuric FSGS despite best supportive and/or oral immunosuppressant therapy (Figure). This study will randomly assign 286 adolescent and adult patients ≥12 years of age with biopsy-confirmed pFSGS, or with a disease-causing TRPC6 GoF mutation, to oral apecotrep 20 mg or matching placebo daily. Key inclusion criteria are: body mass index ≤40 kg/m², weight ≥40 kg, UPCR ≥1500 mg/g, eGFR ≥25 mL/min/1.73 m², and stable background medication. Patients with other monogenic, syndromic, secondary or undetermined FSGS, or those with a renal transplant, will be excluded. The primary endpoint is the relative change in 24-hour UPCR from baseline to Week 104. Key secondary endpoints are the absolute change in eGFR and treatment response (24-hour UPCR <1000 mg/g). The impact on quality of life, need for rescue therapy, and safety will also be assessed. The trial began in February 2026 and is currently enrolling patients from 40 countries. PODOMOUNT-pFSGS will determine whether apecotrep reduces proteinuria and preserves kidney function in adolescents and adults with pFSGS. Further details are available at www.clinicaltrials.gov/study/NCT07220083.

Acknowledgment

Medical writing support for the preparation of this abstract was provided by Iqra Farooq, BSc, and Eve Blumson, PhD, of OPEN Health Communications, and funded by Boehringer Ingelheim, in accordance with Good Publication Practice (GPP) guidelines (www.ismpp.org/gpp-2022).

Funding

• Funding for this abstract was provided by Boehringer Ingelheim.