Abstract: INFO16-SA
PODOMOUNT-Basket: Rationale and Design of a Phase 2 Basket Trial of TRPC6 Inhibitor Apecotrep in Patients with One of Four Proteinuric Glomerular Diseases
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
- Verghese, Priya S., Department of Nephrology, Ann & Robert H. Lurie Children’s Hospital, Chicago, Illinois, United States
- Steubl, Dominik, Boehringer Ingelheim, Ingelheim am Rhein, Germany
- Daza, Eric J., Boehringer Ingelheim, Ridgefield, Connecticut, United States
- Viola, Erika M., Boehringer Ingelheim, Ingelheim am Rhein, Germany
- Trachtman, Howard, University of Michigan, Ann Arbor, Michigan, United States
- Pinter, Jule, Department of Nephrology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany
- Mariani, Laura H., University of Michigan, Ann Arbor, Michigan, United States
- Gale, Daniel P., Department of Renal Medicine, University College London, London, United Kingdom
- Nelson, Delphine Robotham, Boehringer Ingelheim, Ridgefield, Connecticut, United States
Description
Transient receptor potential cation channel, subfamily C, member 6 (TRPC6) is a calcium channel expressed on podocytes. Increased TRPC6 activity leads to excessive calcium influx, resulting in cytoskeletal destabilization, podocyte injury, and proteinuria. Glomerular diseases such as focal segmental glomerulosclerosis (FSGS), minimal change disease (MCD), Alport syndrome, and membranous nephropathy (MN) are characterized by excessive proteinuria, mediated by alterations in podocyte integrity. Apecotrep, a potential first-in-class oral TRPC6 inhibitor, significantly reduced proteinuria compared to placebo in a Phase II trial in primary FSGS and was well tolerated in Phase I and II trials. Podocyte-targeted mechanism of action supports the potential benefit of apecotrep in other podocytopathies.
PODOMOUNT-Basket (NCT07355296) is a Phase II, global, multicenter, randomized, double-blind, placebo-controlled basket trial designed to assess the efficacy, safety, and pharmacokinetics of apecotrep in adults ≥18 years of age with secondary FSGS, Alport syndrome, or treatment-resistant (TR) primary MN; and in adults and adolescents ≥12 years of age with TR primary MCD (Figure 1). Patients remain on stable standard-of-care therapy, including RAAS inhibitors and oral immunosuppressive treatment. Key inclusion criteria are eGFR ≥25 mL/min/1.73 m2 and disease-specific urinary protein-to-creatinine ratio (UPCR) thresholds. Key exclusion criteria are history of organ transplantation and use of intravenous immunosuppressants in the last 6 months. In each disease cohort, patients will be randomized 2:1 to receive oral apecotrep 20 mg or placebo daily for 20 weeks. The primary endpoint is the relative change from baseline to Week 20 in 24-hour UPCR, assessed separately within each cohort. Additional efficacy endpoints and safety outcomes will also be assessed.
An estimated 132 patients will be enrolled across 33 countries. The trial began in March 2026 with completion expected in February 2028. Further details available at www.clinicaltrials.gov/study/NCT07355296.
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
- Boehringer Ingelheim provided funding for the development of this abstract.