NCT02848521

A Study Measuring Quality of Life, Treatment Preference and Satisfaction of ADPKD Patients in Europe

A Prospective, Non-interventional Study Measuring Quality of Life, Treatment Preference and Treatment Satisfaction of Autosomal Dominant Polycystic Kidney Disease Patients in Europe

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 407 (actual)
• Sponsor: Otsuka Pharmaceutical Europe Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, non-interventional study (NIS) measuring health-related quality of life (HRQoL), treatment satisfaction, and other patient-reported outcomes (PROs) of ADPKD patients in Europe.

Detailed description

This is a prospective, non-interventional study (NIS) measuring HRQoL, treatment satisfaction, and other PROs of ADPKD patients in Europe. The study aims to enrol at least 486 patients. Data will be prospectively collected at clinics, from medical notes and via PRO measures for each patient at Baseline, Month 1, Month 3 and subsequently at 3 month intervals up to and including the final assessment (18 months maximum follow-up time). No visits with the patients' treating physician will be imposed by the protocol. Any clinical visits will occur as per normal clinical practice

Conditions

• Autosomal Dominant Polycystic Kidney Disease

Timeline

• Start date: 2016-10-01
• Primary completion: 2019-10-01
• Completion: 2020-03-01
• First posted: 2016-07-28
• Last updated: 2019-04-11

Locations

26 sites across 7 countries: Austria, Belgium, France, Germany, Spain, Switzerland, United Kingdom