FALCON- TRIAL OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE
Enrolling By Invitation
18 years - 70 years
All
Phase
3
7 participants needed
1 Location
Brief description of study
Autosomal dominant polycystic kidney disease (ADPKD) is a multi-organ disorder that results in clusters of fluid-filled cysts in the kidneys and other organs leading to progressive enlargement and loss of organ function. ADPKD is a genetic disorder caused by mutations in the PKD1 and PKD2 genes, which encode the proteins polycystin-1 and -2, respectively. The PKD1 and PKD2 mutations disrupt the function of these proteins within the cilia, forming fluid-filled cysts that progressively increase in size, leading to gross enlargement of the kidneys and distortion of the renal architecture. The disease is the leading inheritable cause of kidney failure; the number of diagnosed patients in the United States is estimated to be between 100,000 and 200,000.
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: polycystic kidney disease,kidney disease,
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Age: 18 years - 70 years
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Gender: All
Updated on
04 Aug 2024.
Study ID: 834776
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