(duplicate) Non-interventional, PASS for patients prescribed JINARC fo

• Research type

  Research Study

• Full title

  A 9-year, Multicentre, Non-interventional, Postauthorisation Safety Study for Patients Prescribed JINARC® for Autosomal Dominant Polycystic Kidney Disease.

• IRAS ID

  225572

• Contact name

  Marco Avila

• Sponsor organisation

  Otsuka Pharmaceutical Europe Ltd

• Duration of Study in the UK

  6 years, 5 months, 1 days

• Research summary

  This PASS is a 6 year, multicentre, prospective, non-interventional study to assess the long-term safety profile of JINARC when prescribed to patients for Autosomal Dominant Polycystic Kidney Disease.

  JINARC (tolvaptan) is currently the only treatment option for slowing the progression of kidney disease in patients with ADPKD, rather than palliative. Study participation will be available to physicians who have completed the appropriate education in all countries in Europe where JINARC is launched and commercially available by prescription. Patients must have never taken tolvaptan previously to be eligible to participate in the study.

  Approximately 3000 patients will participate in the trial globally, with around 600 patients participating in the United Kingdom. Data will be collected from information from routine health check-ups collected from electronic medical records. In addition, a retrospective database analysis will be conducted to compare Adverse Events of special interest, such as glaucoma and skin neoplasms with non-treated patients.

  An Educational Materials Effectiveness Survey will also be conducted to assess physicians' level of awareness and understanding of the content of the educational material received. Physicians who participate in this survey will not be able to enrol patients for prospective follow-up.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  17/NE/0088

• Date of REC Opinion

  18 May 2017

• REC opinion

  Further Information Favourable Opinion