A 9-year, Multicentre, Non-interventional, Post-authorisation Safety Study for Patients Prescribed JINARC® for Autosomal Dominant Polycystic Kidney Disease (JINARC PASS)

Study identification

• EU PAS number:
  EUPAS12842
• Study ID:
  38891
• Official title and acronym:
  A 9-year, Multicentre, Non-interventional, Post-authorisation Safety Study for Patients Prescribed JINARC® for Autosomal Dominant Polycystic Kidney Disease (JINARC PASS)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Finland

  France

  Germany

  Italy

  Luxembourg

  Netherlands

  Norway

  Spain

  Sweden

  Switzerland

  United Kingdom
• Study description:
  This PASS is a multicentre, prospective, observational study of patients being treated with JINARC for ADPKD to better characterise specified known risks in real world treatment through evaluation of AEs and prescribing habits, and collection of data from patients with limited information from clinical trials. 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. Physicians and patients from other regions may also be included for comprehensive or separate analysis. This study does not require any additional diagnostic, therapeutic, or monitoring procedures outside of normal medical practice.
• Study status:
  Finalised

Research institutions and networks

Institutions

Quintiles

Study timelines

Date when funding contract was signed

Actual:28/09/2015

Study start date

Actual:26/09/2016

Date of final study report

Planned:31/12/2025

Actual:20/11/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Otsuka Pharmaceutical Europe Ltd

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)