Abstract: INFO09-SA
A Phase 2 Multicenter, Open-Label, Randomized Study of Two Titration Regimens of Oral CXA-10 in Subjects with Primary Focal Segmental Glomerulosclerosis (FSGS): FIRSTx
Session Information
- Informational Posters - III
November 09, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- No subcategory defined
Authors
- Jorkasky, Diane K., Complexa, Inc., Berwyn, Pennsylvania, United States
- Garner, Rachel, Complexa, Inc., Berwyn, Pennsylvania, United States
- Lafayette, Richard A., Stanford University, Stanford, California, United States
- Sedor, John R., Cleveland Clinic, Cleveland, Ohio, United States
- Fornoni, Alessia, University of Miami, Miami, Florida, United States
- Tuttle, Katherine R., University of Washington School of Medicine, Spokane, Washington, United States
- Spino, Cathie, University of Michigan, Ann Arbor, Michigan, United States
- Gipson, Debbie S., University of Michigan, Ann Arbor, Michigan, United States
Description
The FIRSTx trial is an open-label, randomized phase 2 clinical trial of CXA-10 in patients with incident focal segmental glomerulosclerosis (FSGS).
CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a nitro fatty acid (NO2-FA) formulated for oral administration in clinical development by Complexa, Inc. for FSGS. The molecular interactions driving CXA-10’s pharmacological action include: 1) activation of nuclear factor erythroid 2-related factor 2 (Nrf2) and Heat Shock Response pathways to reduce cellular stress and 2) inhibition of NF-kB and xanthine oxidoreductase to prevent elaboration of pro-inflammatory/pro-fibrotic mediators and ROS.
Unlike most trials for FSGS in which patients are on or resistant to immunosuppressive therapies, this trial is currently enrolling incident patients with biopsy-confirmed FSGS, age 18 years and older, with eGFR > 40 ml/min/1.73m2, UPC > 2, without prior steroid or other immunosuppressive therapy for FSGS, in 23 Kidney Research Network sites in the USA. Collapsing FSGS, chronic infection, pregnancy, and lactation are exclusions. Additional eligibility criteria are listed on clinicaltrials.gov/NCT03422510. Consented and eligible patients are randomized (n=30) to a low or medium dose of CXA-10 administered once daily and are dose escalated at study week 2 to the final dose depending on biomarker response (Figure). The intervention phase includes 90 days of CXA-10 oral therapy with a 28-day post-therapy follow up phase. Pharmacodynamic and pharmacokinetic assessments are being conducted. The primary outcomes are percent change in UPC from baseline to day 90 and safety. Planned statistical analysis includes testing of pooled within-subject changes in proteinuria, as well as comparison of UPC and eGFR in study subjects to historical controls.
Additional information can be found at www.FIRSTx-trial.com.
Funding
- Complexa, Inc.