Division of Nephrology Clinical Studies

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CARDINAL

Researchers want to find out if bardoxolone methyl, a drug being developed by Reata Pharmaceuticals, can improve Alport Syndrome, with its disease-modifying effects in kidney function. Bardoxolone methyl is an investigational (experimental) drug that is being tested, and is not currently approved by the U.S. Food and Drug Administration (FDA), or any other regulatory agency for sale in the United States or any other country.  In this study, bardoxolone methyl will be given to approximately 210 patients with Alport Syndrome from approximately 60 study centers who are between the ages of 12 and 60.  The trial will consist of two cohorts (i.e. groups). Cohort 1 is considered a Phase 2 study, and will enroll up to 30 subjects.  Cohort 1 will be open-label where everyone involved in the study (including you) know that the study drug being used will ONLY be bardoxolone methyl capsules.  CHOP will not be participating in Cohort 1.

Cohort 2 will be a double-blind, randomized, placebo-controlled, Phase 3 study, and will enroll up to 180 subjects.  This means that you will be randomly assigned (like flipping a coin) to either bardoxolone methyl, or a placebo (i.e. inactive substance/sugar pill), and that both you AND your doctor will not know which drug you are assigned to. IRB 17-013989

Novel Imaging in Autosomal Recessive Polycystic Kidney Disease

In this study, we are developing new ultrasound and magnetic resonance imaging (MRI) methods to measure kidney and liver disease severity in autosomal recessive polycystic kidney disease (ARPKD). Participants in this study will include individuals with ARPKD, and a comparison group of healthy individuals without liver or kidney disease. Individuals of any age may take part in the study. Study procedures include an ultrasound and MRI scan of the abdomen (MRI is only done in participants able to lie still for up to an hour, generally at least 8 years old). Participants wtih ARPKD will also have a blood test and will be asked to complete 1 follow up visit per year for up to 3 years after baseline.