Clinical Trial: Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official 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

Brief Summary: The purpose of the study is to evaluate and describe the long term safety of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD

Detailed Summary: This trial is a phase 3b to evaluate and describe the long-term safety of tolvaptan treatment in ADPKD patients with CKD (chronic kidney disease). Eligible Subjects will enter the trial from Trial 156-08-271 or other Tolvaptan interventional trials. Renal function will be assessed during screening by using historical laboratory values for serum creatinine levels to calculate the estimated glomerular filtration rate (eGFR). General safety endpoints will be assessed and also relevant safety endpoints for the trial as Serum transaminase elevations in frequency & Serum sodium excursions.
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Current Primary Outcome: Safety variables [ Time Frame: From Baseline ]

Clinically significant changes from baseline in abnormal clinical laboratory tests, vital signs and AEs will be summarized.The incidence of the following events will be summarized:

  1. Treatment-emergent AEs (TEAEs) by severity
  2. TEAEs potentially causally related to tolvaptan
  3. TEAEs with an outcome of death
  4. Serious TEAEs
  5. Discontinuations due to TEAEs

Clinically significant serum transaminase elevations will be summarized by frequency (2x, 3x, 5x and 10x ULN), time to onset, time to peak levels, time to offset (< 3x, 2x, or 1x ULN)

Frequency of progression to Hy's laboratory criteria (ALT or AST > 3x ULN and bilirubin, total (BT), > 2x ULN without alkaline phosphatase > 2x ULN)

Serum sodium excursions above 145, 150, or 155 mmol/L or below 135, 130, or 125 mmol/L



Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Otsuka Pharmaceutical Development & Commercialization, Inc.

Dates:
Date Received: September 25, 2014
Date Started: September 2014
Date Completion:
Last Updated: April 24, 2017
Last Verified: April 2017