01-04-2019 Update
Reata Management Call to Discuss Phase 3 ADPKD Study Design
Overview
- ADPKD is the leading, inheritable cause of kidney failure in the US, occurring in approximately 116,000 patients1
- ADPKD is a genetic form of CKD caused by mutations in the PKD1 and PKD2 genes1-3
- Genetic mutations cause the formation of fluid-filled cysts in the kidneys1-3
- Cyst growth displaces normal kidney tissue, triggers an immune response leading to interstitial inflammation and fibrosis, and results in progressive loss of kidney function and eventual kidney failure1-3
PHOENIX Trial Overview
PHOENIX was an open-label, multicenter, phase 2 US trial designed to evaluate the safety, tolerability, and efficacy of bardoxolone methyl in four separate patient cohorts. The target enrollment is 25 to 30 patients per cohort.
PHOENIX Trial Details
- Patient cohorts: ADPKD, IgAN, T1D CKD, and FSGS
- Age: 18-65 years
- eGFR: 30-90 mL/min/1.73 m2
- Primary endpoint: change from baseline in eGFR at week 12
- Treatment: bardoxolone methyl, orally, once-daily for 12 weeks
PHOENIX Trial Design
References
- National Human Genome Research Institute. Learning about autosomal dominant polycystic kidney disease. http://www.genome.gov/20019622/learning-about-autosomal-polycystic-kidney-disease. Accessed November 7, 2018.
- Chebib FT, Torres VE. Autosomal dominant polycystic kidney disease: Core curriculum 2016. Am J Kidney Dis. 2016;67(5):792-810.
- Li X, Magenheimer BS, Xia S, et al. A tumor necrosis factor-alpha-mediated pathway promoting autosomal dominant polycystic kidney disease. Nat Med. 2008;14(8):863-868.
