Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Principal Investigator: Patrick Nachman, MD
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC)
Age Range: 18 to 65 years of age
Status: Ongoing – enrollment closed
Purpose: The purpose of this open label extension research trial is to study the potential long-term benefits and safety of tolvaptan in individuals with Autosomal Dominant Polycystic Kidney Disease (ADPKD). The kidneys of people with ADPKD respond abnormally to the hormone vasopressin, which may be involved in cyst development or growth in humans. Tolvaptan interferes with vasopressin’s effects on the kidney and, when taken continually, appears to block cyst growth in laboratory animals with PKD.
Study Procedures: During study visits, participants will undergo blood draw, urine collection, review of medications, and vitals. All participants take tolvaptan.
Participation: Participants will have a study visit every 3 months until the end of the study. The length of the study is still to be determined.
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