Autosomal Polycystic Kidney Disease
A double-blind, placebo controlled study comparing Tolvaptan 45-120mg/day in a split dose.
The purpose of this study is to test the benefit and safety of Tolvaptan for the treatment of Autosomal Polycystic Kidney Disease.
Key Inclusion Criteria
- 18-65 years old
- Male and Females with eGFR between 25-65 mL/min/1.73m2 for ages between 18-55, or eGFR between 25-44-mL/min/
- Tolvaptan naive
- Diagnosis of ADPKD by modified pei-Ravine criteria1.3 cysts per kidney by sonography or 5 cysts by CT or MRI with family history or 2.10 cysts per kidney by any radiologic method and exclusion of other cystic kidney disease if without family history
Key Exclusion Criteria
- Women of childbearing potential who do not practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the trial.
- Women who are breast-feeding and/or who have a positive pregnancy test prior to receiving study drug
- Need for chronic diuretic use
- Hepatic impairment or liver function abnormalities other than that expected for ADPKD with typical cystic liver disease
- Advanced diabetes, evidence of additional significant renal disease, renal cancer, single kidney, recent renal surgery or acute kidney injury
- Contraindications to required trial assessments
- Medical history or medical findings inconsistent with safety or compliance with trial assessments