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A Trial of Bardoxolone Methyl in Patients with ADPKD (FALCON)

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. Approximately 300 patients will be enrolled.

Patients will be randomized 1:1 to either bardoxolone methyl or placebo. Patients receiving bardoxolone methyl will start with once-daily dosing at 5 mg and will dose-escalate to 10 mg at Week 2, to 20 mg at Week 4, and then to 30 mg at Week 6 unless safety or tolerability concerns arise.

All patients in the study will follow the same visit and assessment schedule. Following randomization on Day 1, patients will be scheduled to be assessed during treatment at Weeks 1, 2, 4, 6, 8, 12, 24, 36, 48, 52, 64, 76, 88, 100, and 104 and by telephone contact on Days 3, 10, 21, 31, 38, and 45.

 

Intervention/Treatment: Drug: Bardoxolone methyl oral capsule
Other: Placebo oral capsule

 

Participation Criteria:
Inclusion Criteria:
● Male and female patients 18 ≤ age ≤ 70
● Diagnosis of ADPKD
● Screening eGFR ≥ 30 to≤ 90 mL/min/1.73 m2 (18 to 55 years) or ≥ 30 to ≤ 44 mL/min/1.73 m2 (56 to 70 years):
Patients with either screening eGFR ≥ 60 to ≤ 90 mL/min/1.73 m2 or age 56 to 70 years, must have evidence of ADPKD progression (i.e., eGFR decline of ≥ 2.0 mL/min/1.73 m2 per year, based on historical eGFR data)
● Blood pressure no lower than 140/80 mmHg. Patients receiving an angiotensin-converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB) must be on a stable dose for at least 6 weeks prior to the Screen A visit.

Exclusion Criteria:
● Uncontrolled diabetes (HbA1c > 11.0%)
● History of intracranial aneurysms;
● Kidney or any other solid organ transplant recipient or a planned transplant during the study;
● Acute dialysis or acute kidney injury within 12 weeks prior to Screen A visit or during Screening;
● History of clinically significant left-sided heart disease and/or clinically significant cardiac disease;
● Systolic BP < 90 mmHg;
● BMI < 18.5 kg/m2;
● History of intracranial aneurysms;
● History of malignancy within 5 years prior to Screen A visit, with the exception of localized skin or cervical carcinomas;
● Systemic immunosuppression for more than 2 weeks, cumulatively, within the 12 weeks prior to randomization or anticipated need for immunosuppression during the study;
● Untreated or uncontrolled active bacterial, fungal, or viral infection;
● Participation in other interventional clinical studies within 30 days prior to Day 1;
● Unwilling to practice acceptable methods of birth control (both males who have partners of child-bearing potential and females of childbearing potential) during Screening, while taking study drug, and for at least 30 days after the last dose of study drug is ingested;
● Women who are pregnant or breastfeeding;

 

Contact Information:
Study Manager
+1 469-442-4754
FALCON@reatapharma.com

 

Locations:
Port Charlotte, Florida; Meridian, Idaho; Shreveport, LA; Kansas City, MO; Asheville, NC; Columbus, OH; Columbia, SC; Austin, TX; San Antonio, TX
Age range: 18-70
Stage: Recruiting
Status: Active

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