Clinical Trials

Inclusion Criteria

• Male or female 
• ≥ 18 years
• Confirmed diagnosis of Autosomal dominant polycystic kidney disease (during participation in prior tolvaptan trials) who have
  • Completed and transferred from the double-blind trial 156-13-210 (12-month period including post treatment follow-up, regardless of whether this was on-treatment or off-treatment) or
  • Completed Trial 156-08-271 or a prior tolvaptan trial or
  • Interrupted or discontinued treatment in a prior tolvaptan trial other than trial 156-13-210
    • Subjects may be enrolled with the medical monitor approval, and additional close monitoring may be required at the beginning of the study
• Estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73m2 within 45 days of the baseline visit
  • An eGFR between 15 and 19 mL/min/1.73m2 may be enrolled with medical monitor approval
• Diagnosis of ADPKD by modified Pei-Ravine criteria

Exclusion Criteria

• Need for chronic diuretic use
• Hepatic impairment based on liver function assessments other than that expected for ADPKD with cystic liver disease
• Women of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of IMP
• Women who are breast-feeding and/or who have a positive pregnancy test result prior to receiving IMP
• Have contraindications to required trial assessments (contraindications to optional assessments, eg, MRI are not a limitation)
• Have a medical history or medical finding inconsistent with safety or trial compliance in the opinion of the Investigator or the Medical Monitor