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

Autosomal Dominant Polycystic Kidney Disease Clinical Trial

— ACQUIRE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02848521
• Other study ID #: 156-303-00096
• Status: Active, not recruiting
• Start date: October 2016
• Est. completion date: March 2020

Study information

• Verified date: September 2018
• Source: Otsuka Pharmaceutical Europe Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 407
• Est. completion date: March 2020
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Autosomal Dominant Polycystic Kidney Disease
• Kidney Diseases
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

Locations

Country	Name	City	State
Austria	AKH Wien	Vienna
Austria	LKH Villach	Villach
Belgium	UCL Brussels	Brussels
Belgium	UZ Brussels	Brussels
Belgium	UZ Leuven/Gasthuisberg KUL	Leuven
Belgium	CHU Liège - Domaine Universitaire du Sart Tilman	Liege
France	Clinique La Louviere	Lille
France	CHU Nimes - Hôpital CAREMEAU	Nimes
France	Hopital Tenon	Paris
France	Necker Hospital	Paris
France	CHU TOURS - Hôpital Bretonneau	Tours
Germany	Charite Berlin	Berlin
Germany	Universitätsmedizin Göttingen	Gottingen
Germany	University Medical Center Schleswig-Holstein	Lubeck
Spain	Fundación Puigvert	Barcelona
Spain	Hospital Clinic	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital Universitario de Getafe	Getafe
Switzerland	University Hospital of Geneve	Genève
Switzerland	University Hospital of Zurich	Zürich
United Kingdom	Edinburgh Royal Infirmary	Edinburgh
United Kingdom	Queen Elizabeth University Hospital	Glasgow
United Kingdom	Aintree University Hospital	Liverpool
United Kingdom	Royal Free Hospital	London
United Kingdom	Royal London Hospital	London
United Kingdom	Freeman Hospital	Newcastle

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Europe Ltd

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean ADPKD-Pain and Discomfort Scale(PDS) score change from baseline to end of study (exploratory)	Mean ADPKD-PDS score change from baseline to end of study, in the overall sample and per CKD stage (dull kidney pain, sharp kidney pain and fullness/discomfort domain scores will be reported and analysed)	From Baseline to end of study (maximum of 18 months)
Other	Overall odds ratio of discrete-choice experiment (DCE) for patient preference to the addition of a disease modifying treatment versus no change to local Standard of Care (SoC)	A descriptive of discrete-choice experiment (DCE) will be presented at baseline and at 18 months. Data from the DCE survey will be analysed using a conditional logit model. This explores the impact of each attribute (independent variable) on the patients' choice (dependent variable). Overall odds ratio of DCE for preference to the addition of a disease modifying treatment versus no change to local SoC will be displayed. The relationship between attributes of treatment and overall treatment preference as captured in DCE and relationship between stated DCE attribute preferences and persistence to ADPKD treatments will also be analysed.	At baseline and at the end of the study (18 months)
Primary	Mean rate of change (%) in Physical Health Composite Scale (PCS) scores of the 12-Item Short Form Survey (SF-12)	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.	From Baseline to end of study (maximum of 18 months)
Secondary	Mean rate of change (%) in Mental Health Composite Scale (MCS) scores of the SF-12	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.	From Baseline to end of study (maximum of 18 months)
Secondary	Mean ADPKD-IS score changes	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).	From Baseline to end of study (maximum of 18 months)
Secondary	Mean Treatment Satisfaction Questionnaire for Medication (TSQM-9) score changes	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).	From Baseline to end of study (maximum of 18 months)
Secondary	Mean ADPKD-Urinary Impact Scale (UIS) score changes	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).	From Baseline to end of study (maximum of 18 months)
Secondary	Description of real-world ADPKD treatment patterns (number of subjects taking different treatments)		From Baseline to end of study (maximum of 18 months)
Secondary	Description of real-world ADPKD treatment patterns (percentage of subjects taking different treatments)		From Baseline to end of study (maximum of 18 months)