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A Phase 2a, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX-407 in Subjects with Autosomal Dominant Polycystic Kidney Disease Who Have a Subset of PKD1 Gene Variants
Status: Recruiting
To evaluate the efficacy, safety, and pharmacokinetics of VX-407 in participants with Autosomal Dominant Polycystic Kidney Disease with PKD1 gene variants
Sex: Male or Female
Age Group: 18 years and over
Inclusion Criteria:
• Participants between the ages of 18 and 65 years, inclusive.
• Willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures
• participants with a pre-existing diagnosis of autosomal dominant polycystic kidney disease (ADPKD)
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:
• Kidney disease other than ADPKD that in the opinion of the investigator would independently impact the natural history of ADPKD
• Solid organ or bone marrow transplantation, or nephrectomy
• Any condition possibly affecting drug absorption (e.g., gastrectomy, gastrointestinal tract surgery except appendectomy and cholecystectomy
• Clinically significant liver dysfunction
Interventions:
Drug: VX-407
Conditions:
Kidney, Prostate & Urinary, Rare Diseases
Keywords:
autosomal dominant polycystic kidney disease (ADPKD), kidney disease, Clinics and Surgery Center (CSC)
Study Contact: Katherine Wu - wuxx1320@umn.edu
Principal Investigator: Katti Woerner
Phase: PHASE2
IRB Number: STUDY00026103
See this study on ClinicalTrials.gov