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.

Skeletal and Dental Quality in Adolescents with Urinary Stone Disease

Urinary stone disease (USD) is a common, chronic disorder and today is seen more frequently in adolescence than in the past. Current understanding of its impact on bone development and structure as well as dental health is not known. We will be evaluating bone and dental quality in 70 children/adolescents with USD and 70 healthy children/adolescents. The study requires: two to three visits for a total of three to four hours, that the participant be 5-21 years old, and compensation will be provided. If interested in participating contact the research coordinator at 267-648-3256.

Tesevatinib in autosomal recessive polycystic kidney disease (ARPKD)

This study is open to children with ARPKD aged 5-12 years old whose kidney function is at least 50% of normal (glomerular filtration rate [GFR] >50). The purpose of this research study is to find out if a new investigational drug, tesevatinib, is safe as a possible treatment for children with ARPKD at various doses. The study is also being done to learn about the pharmacokinetics of tesevatinib, which means how the body takes the drug into the blood, how the drug spreads out in the body, and how it is broken down and removed from the body. This is a Phase 1 study, which means that the study is designed to find the highest dose of tesevatinib that can be safely given to children.

BoneGN

Glomerular disease is a major cause of chronic kidney disease associated with substantial morbidity; children and adults with glomerular disease face many threats to bone health. The purpose of this research study is to understand more about bone strength in children, adolescents and adults with Glomerular disease. This and future research will help us develop treatment guidelines for this population in order to promote bone health and prevent fractures and osteoporosis later in life. We will be evaluating bone quality in 150 participants with Glomerular disease and 120 healthy participants. The study requires 2 visits for a total of 3 hours and that the participants be 5 to 55 years old. The study procedures include blood draws, bone density measures and questionnaires. Compensation will be provided. If interested in participating contact the research coordinator at 267-648-3256.