A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease

Phase 3

Completed

Conditions: Autosomal Dominant Polycystic Kidney Disease
10029149

Registration Number: NL-OMON41781

Lead Sponsor: Quintiles

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 69

Inclusion Criteria

Male and female subjects aged >18 years with ADPKD who have completed 156-13-210, or who have participated in a previous tolvaptan ADPKD trial and do not qualify for 156-13-210.

Exclusion Criteria

1. Women of child bearing potential who are unwilling to adhere to abstinence or double-barrier contraceptive requirements
2. Women who are breast-feeding and/or who have a positive pregnancy test result prior to receiving IMP.
3. Need for chronic diuretic use
4. Hepatic impairment based on liver function or abnormalities other than that expected for ADPKD with cystic liver disease during screening
5. Subjects with contraindications to required trial assessments (contraindications to optional assessments, eg MRI, are not a limitation)
6. Subjects who, in the opinion of the trial investigator or Medical Monitor, have a medical history or medical findings inconsistent with safety or compliance with trial. This includes prior evidence of significant hepatic injury deemed to be related to tolvaptan use.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety: AEs, vital signs, clinical laboratory assessments, serum transaminase<br /><br>elevations for frequency (2x, 3x, 5x and 10x ULN), time to onset, time to peak<br /><br>levels, time of offset (< 3x, 2x, or 1x ULN), response to de-challenge and<br /><br>re-challenge and frequency of progression to Hy*s laboratory criteria (ALT or<br /><br>AST > 3x ULN and BT > 2x ULN without alkaline phosphatase 2x ULN), Serum sodium<br /><br>excursions above 145, 150, or 155 mmol/L or below 135, 130, or 125 mmol/L. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Exploratory: PKD outcomes survey, Medical resource utilization<br /><br>(office/emergency room, healthcare visits, hospital admissions, procedures and<br /><br>therapies) and productive days lost due to PKD outcomes as part of the ADPKD<br /><br>outcomes surve.</p><br>