A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON (FALCON)
- Conditions
- Autosomal Dominant Polycystic Kidney Disease
- Registration Number
- JPRN-jRCT2080225066
- Lead Sponsor
- Reata Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- terminated
- Sex
- All
- Target Recruitment
- 850
Male and female patients 12 =< age =< 70 upon study consent;
-History of administration of polycystic kidney disease-modifying agents (somatostatin analogues) within 3 months prior to the Screen A visit;
-B-type natriuretic peptide (BNP) level > 200 pg/mL at Screen A visit;
-Uncontrolled diabetes (HbA1c > 11.0%) at Screen A visit;
-Serum albumin < 3 g/dL at Screen A visit;
-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 mm Hg at Screen A visit after a period of rest;
-BMI < 18.5 kg/m2 at the Screen A visit;
-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;
-Concomitant use of tolvaptan is excluded. Patients previously treated with tolvaptan must have discontinued drug for at least 3 months prior to Screen A visit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the off-treatment change from baseline in eGFR at Week 108 for patients receiving active drug, compared to patients receiving placebo.
- Secondary Outcome Measures
Name Time Method To assess the off-treatment change from baseline in eGFR at Week 100 for patients receiving active drug, compared to patients receiving placebo.