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Phoenix


Title A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients with Rare Chronic Kidney Diseases
Therapeutic Area Chronic Kidney Disease
Principal Investigator Lesley Inker, MD, MS
Min Age 18 Years
Max Age 65 Years
Gender Any
Contact Sara Couture
617-636-8783
More Information https://www.clinicaltrials.gov/ct2/show/NCT03366337

Overview

PHOENIX is a phase 2 trial evaluating the safety and effectiveness of bardoxolone methyl in patients with rare chronic kidney diseases: CKD associated with type 1 diabetes (T1D), IgA nephropathy (IgAN), focal segmental glomerulosclerosis (FSGS), and autosomal dominant polycystic kidney disease (ADPKD). 

Study Details

Inclusion Criteria

Must be diagnosed with one of the following conditions:

  • Autosomal Dominant Polycystic Kidney Disease (ADPKD): Genetic confirmation of PKD1
  • CKD associated with type 1 diabetes (T1D): Diagnosed with Type 1 Diabetes < 35 years of age
  • Focal Segmental Glomerulosclerosis (FSGS): Biopsy-confirmed FSGS
  • IgA nethropathy (IgAN): Biopsy-confirmed IgA nephropathy

Exclusion Criteria

Kidney or any other solid organ transplant recipient or planned transplant during the study;

Study Requirements

Study participation will last 16 weeks, and include two screening visits, baseline visit, and a total of 7 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/or biopsy (if needed). The week 12 visit will include administering the last dose, 3 timed blood draws and EKG. The week 16 visit is a 4 week follow up after the last dose is administered, and includes an EKG. 

After the baseline visit, patients will be assigned to the Bardoloxone or placebo group, and will increase dose gradually to maximum dose until week 12.