A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Autosomal Dominant Polycystic Kidney, ADPKD

In brief

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 850 patients will be enrolled.

Key facts

Study ID

NCT03918447

Run by

Biogen

People needed

667

Starts

2019-05-29

Expected to finish

2023-08-08

Last updated by the study team

2025-06-03

Who can join

Age: 12 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients 12 ≤ age ≤ 70 upon study consent;
• Diagnosis of ADPKD by modified Pei-Ravine criteria (for adults 18≤ age ≤70 years): 1) at least 3 cysts per kidney by sonography or at least 5 cysts by CT or MRI with family history of ADPKD or 2) at least 10 cysts per kidney by any radiologic method and exclusion of other cystic kidney diseases if without family history;
• Screening eGFR (average of Screen A and Screen B eGFR values) ≥ 30 to≤ 90 mL/min/1.73 m2 (12 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 and medical monitor discretion); 2)The two eGFR values collected at Screen A and Screen B visits used to determine eligibility must have a percent difference ≤ 25%;
• Albumin to creatinine ratio (ACR) ≤ 2500 mg/g at Screen B visit;
• Systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg at Screen A or B visit after a period of rest.

You may not qualify if…

• History of administration of polycystic kidney disease-modifying agents (somatostatin analogues) within 2 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 2 months prior to Screen A visit

Where it is running

• Nephrology Associates PC — Homewood, Alabama, United States
• Nephrology Consultants, LLC — Huntsville, Alabama, United States
• AKDHC — Glendale, Arizona, United States
• Aventiv Research, Inc — Mesa, Arizona, United States
• University of Arizona — Tucson, Arizona, United States
• Rancho Research Institute — Downey, California, United States
• California Institute Renal Research — La Mesa, California, United States
• University of California, Los Angeles — Los Angeles, California, United States
• Keck USC/LAC — Los Angeles, California, United States
• Amicis Research Center — Northridge, California, United States
• Stanford University — Palo Alto, California, United States
• Apex Research of Riverside — Riverside, California, United States
• University of California San Francisco — San Francisco, California, United States
• Western Nephrology — Arvada, Colorado, United States
• University of Colorado Anschutz Medical Center — Aurora, Colorado, United States
• Kidney Associates of Colorado — Denver, Colorado, United States
• Denver Nephrologist, PC — Denver, Colorado, United States
• Western Nephrology and Mineral Bone Disease, PC — Westminster, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• University of Miami — Miami, Florida, United States
• Pro-Care Research Center, Corp. — Miami Gardens, Florida, United States
• Discovery Medical Research Group — Ocala, Florida, United States
• Innovation Medical Research Center, Inc — Palmetto Bay, Florida, United States
• Volunteer Medical Research — Port Charlotte, Florida, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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