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

• Conditions: Autosomal Dominant Polycystic Kidney Disease

• Registration Number: NCT02848521
• Lead Sponsor: Otsuka Pharmaceutical Europe Ltd

Brief 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

Study Timeline

• Study First Submitted: 2016-07-21
• Study First Submitted QC: 2016-07-25
• Study First Posted: 2016-07-28
• Study Start: 2016-10
• Status Verified: 2018-09
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-11
• Primary Completion: 2019-10
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 407

Inclusion Criteria

• Male and female aged ≥ 18 years.
• Patient has a diagnosis of ADPKD between CKD Stages 1-3, and is deemed by their treating physician to likely have rapidly progressing disease.
• Patient has a life expectancy greater than 18 months at time of enrolment.
• Patient is able and willing to give informed consent, if required according to local regulations.
• Patient is fluent in local language.

Exclusion Criteria

• Patient is currently participating in, or has in the last 12 months participated in an interventional clinical trial.
• Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient.
• Inability of the patient to complete PROs remotely.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean rate of change (%) in Physical Health Composite Scale (PCS) scores of the 12-Item Short Form Survey (SF-12)	From Baseline to end of study (maximum of 18 months)	Mean rate of change (%) in Physical Health Composite Scale (PCS) scores of the SF-12 from baseline to end of study, in the overall sample and per chronic kidney disease (CKD) stage.

Secondary Outcome Measures

Name	Time	Method
Description of real-world ADPKD treatment patterns (percentage of subjects taking different treatments)	From Baseline to end of study (maximum of 18 months)
Mean Treatment Satisfaction Questionnaire for Medication (TSQM-9) score changes	From Baseline to end of study (maximum of 18 months)	Mean TSQM-9 score changes from baseline to end of study, in the overall sample and per CKD stage (effectiveness, convenience and global satisfaction domain scores will be reported and analysed).
Mean ADPKD-IS score changes	From Baseline to end of study (maximum of 18 months)	Mean ADPKD-IS scores changes from baseline to end of study, in the overall sample and per CKD stage (physical, emotional and fatigue domain scores will be reported and analysed).
Mean rate of change (%) in Mental Health Composite Scale (MCS) scores of the SF-12	From Baseline to end of study (maximum of 18 months)	Mean rate of change (%) in Mental Health Composite Scale (MCS) scores of the SF-12 from baseline to end of study, in the overall sample and per CKD stage.
Mean ADPKD-Urinary Impact Scale (UIS) score changes	From Baseline to end of study (maximum of 18 months)	Mean ADPKD-UIS score changes from baseline to end of study, in the overall sample and per CKD stage (frequency, urgency and nocturia domain scores will be reported and analysed).
Description of real-world ADPKD treatment patterns (number of subjects taking different treatments)	From Baseline to end of study (maximum of 18 months)

Trial Locations

Locations (26)

AKH Wien; 🇦🇹 Vienna, Austria

LKH Villach; 🇦🇹 Villach, Austria

UCL Brussels; 🇧🇪 Brussels, Belgium

UZ Brussels; 🇧🇪 Brussels, Belgium

UZ Leuven/Gasthuisberg KUL; 🇧🇪 Leuven, Belgium

CHU Liège - Domaine Universitaire du Sart Tilman; 🇧🇪 Liege, Belgium

Clinique La Louviere; 🇫🇷 Lille, France

CHU Nimes - Hôpital CAREMEAU; 🇫🇷 Nimes, France

Hopital Tenon; 🇫🇷 Paris, France

Necker Hospital; 🇫🇷 Paris, France

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