Overview
- Approximately 1.3 million US adults were diagnosed with T1DM in 20161,2
- More than one-fifth of individuals (125,000 to 200,000 patients in the US) with T1DM are expected to develop CKD, the leading cause of mortality in T1D CKD patients2
- Hyperglycemia, high levels of sugar in the blood, initiates pathological pathways, including inflammation, that lead to structural changes in the kidney, such as glomerulosclerosis, which can progress to ESRD3
PHOENIX Trial Overview
PHOENIX is 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
- Bullard KM, Cowie CC, Lessem SE, et al. Prevalence of diagnosed diabetes in adults by diabetes type—United States, 2016. MMWR Morb Mortal Wkly Rep. 2018;67(12):359-361.
- Piscitelli P, Viazzi F, Fioretto P, et al. Predictors of chronic kidney disease in type 1 diabetes: A longitudinal study from the AMD Annals initiative. Sci Rep. 2017;7(1):3313.
- Duran-Salgado MB, Rubio-Guerra AF. Diabetic nephropathy and inflammation. World J Diabetes. 2014;5(3):392-398.
