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Cardinal


Title A Phase 2/3 Trial of the Efficacy and Safety of Bardolxolone Methyl in Patients with Alports Syndrome
Therapeutic Area Renal Disease, Alports Syndrome
Principal Investigator Lesley Inker, MD, MS
Min Age 12 Years
Max Age 60 Years
Gender All
Contact Sara Couture
617-636-8783
More Information https://clinicaltrials.gov/ct2/show/NCT03019185

Overview

CARDINAL is a Phase 2/3 clinical study evaluating the safety and effectiveness of bardoxolone methyl (an oral investigational drug) for the treatment of Alport syndrome

Study Details

Inclusion Criteria

  • Diagnosis of Alports Syndrome (if genetic testing is needed, the cost is covered)

Exclusion Criteria

  • Receiving Dialysis
  • Renal Transplant Recipient

Study Requirements

Study participation will last 2 years, and include two screening visits, baseline visit, and a total of 16 follow-up visits and 6 scheduled phone calls.

Study visits at Tufts Medical center will include surveys of symptoms, a blood draw, and urine collection

The screening visit will also include an Echo and EKG and a genetic test (if needed). The week 12 visit will included 3 timed blood draws

After the baseline visit, patients will be assigned to the Bardoloxone group or placebo group, and will increase dose gradually to maximum dose.