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A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON

NCT03918447 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 667

Last updated 2025-06-03

Study results available
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Summary

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.

Conditions

  • Autosomal Dominant Polycystic Kidney
  • ADPKD

Interventions

DRUG

Bardoxolone methyl oral capsule

Bardoxolone methyl capsules dose escalated from 5 mg to a maximum of 20 or 30 mg, depending on baseline proteinuria status.

DRUG

Placebo oral capsule

Capsule containing an inert placebo

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-29
Primary Completion
2023-08-08
Completion
2023-08-08
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Czechia
  • France
  • Germany
  • Italy
  • Japan
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03918447 on ClinicalTrials.gov