156-13-211: Open-Label Trial to Evaluate Long Term Safety of Tolvaptan
Research type
Research Study
Full title
A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease.
IRAS ID
164169
Contact name
Neil Turner
Contact email
Sponsor organisation
Otsuka Pharmaceutical Development and Commercialisation, Inc.
Eudract number
2014-001516-19
Duration of Study in the UK
3 years, 10 months, 14 days
Research summary
Tolvaptan is being studied in this study as a possible treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD), a disease that causes kidney cysts, other kidney disease symptoms, and sometimes symptoms in other areas of the body. For people with ADPKD, the kidneys respond abnormally to the hormone vasopressin that may be involved in cyst development or growth in humans. Tolvaptan interferes with the effect of vasopressin on the kidney, and reduces cyst growth when given to animal models of ADPKD.
The study duration is planned to continue until the last subject from Trial 156-13-210 completes 18 months of tolvaptan treatment in this trial. Subjects enrolling from other tolvaptan trials will conclude their participation once tolvaptan becomes available either through routine prescription, a compassionate use or named-patient program. Subjects from study 156-13-210 may opt to conclude their participation in this trial if tolvaptan becomes available before they complete 18 months of treatment in this trial.
The final visit assessments from the previous protocol can be combined with the screening visit for this trial, as long as the time between the visits is within 30 days. Patients who have already received tolvaptan for at least 18 months will return for a study visit every 3 months to assess safety and tolerability of the study drug.
Patients who have not yet received tolvaptan for 18 months will return for monthly visits until the 18-month threshold is reached, after which they will return every 3 months. A follow up visit will be performed seven days following the final study visit.
Patients demonstrating a liver abnormality will be asked to provide an optional blood sample for DNA (genetic) testing, unless already provided in a previous trial. Additional study visits and blood tests will be performed to closely monitor any liver abnormality.REC name
Scotland A: Adults with Incapacity only
REC reference
14/SS/1087
Date of REC Opinion
22 Dec 2014
REC opinion
Further Information Favourable Opinion