Back to Results

FALCON


Title A Phase 3 Trial Of The Efficacy And Safety Of Bardoxolone Methyl In Patients With Autosomal Dominant Polycystic Kidney Disease
Therapeutic Area Polycystic Kidney Disease
Principal Investigator Ronald Perrone, MD
Min Age 18 Years
Max Age 70 Years
Gender All
Contact Phoenix Turoci / Nicole Merullo
617-636-7914 / 617-636-8117
pturoci@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT03918447

Overview

This international, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with ADPKD.

The primary objectives of this study is assess the off-treatment change from baseline in estimated glomerular filtration rate (eGFR) at Week 52 or following a 4-week drug treatment withdrawal period in the first year of treatment and to assess safety and tolerability.

Study Details

Inclusion Criteria

  • Diagnoses of ADPKD by cyst count,
  • Estimated glomerular filtration rate between 30 to 90 mL/min/1.73 m2 (18-55 years old) and 30-44 mL/min/1.73 m2 (56-70 years old),
  • Systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg at Screen A visit (patients on a blood pressure stabilizing medication must be on a stable dose for at least 6 weeks prior to Screen A)

Exclusion Criteria

  • Uncontrolled hypertension
  • Currently taking Tolvaptan
  • Patient is immunocompromised

Study Requirements

Length of participation is 104 weeks. There is a 4-week period off of study drug between Week 48 and Week 52. There is a blood draw and urine sample done at every study visit. Patients record their weight every day with a scale provided by the study sponsor. There is an echocardiogram at the Screen A visit.