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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started

Description

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

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 Autosomal Dominant Polycystic Kidney Disease

Details

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.

Keywords

Autosomal Dominant Polycystic Kidney Disease Tolvaptan

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Male and female subjects ≥ 18 years with confirmed diagnosis of ADPKD (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 ADPKD 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
  2. Estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73m2 within 45 days of the baseline visit. Subjects who have an eGFR between 15 and 19 mL/min/1.73m2 may be enrolled with medical monitor approval
  3. Diagnosis of ADPKD by modified Pei-Ravine criteria

You CAN'T join if...

  • 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 (WOCBP) 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.
  • Subjects with contraindications to required trial assessments (contraindications to optional assessments, eg, MRI are not a limitation).
  • Subjects who in the opinion of the Investigator or the Medical Monitor, have a medical history or medical finding inconsistent with safety or trial compliance

Locations

  • Stanford, California, 94305, United States
  • Sparks, Nevada, 89434, United States
  • Los Angeles, California, 90025, United States
  • Los Angeles, California, 90022, United States
  • Las Vegas, Nevada, 89128, United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
ID
NCT02251275
Phase
Phase 3
Study Type
Interventional
Last Updated
June 1, 2017