A Study Measuring Quality of Life, Treatment Preference and Satisfaction of ADPKD Patients in Europe
ACQUIRE
A Prospective, Non-interventional Study Measuring Quality of Life, Treatment Preference and Treatment Satisfaction of Autosomal Dominant Polycystic Kidney Disease Patients in Europe
1 other identifier
observational
407
7 countries
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2016
Typical duration for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2016
CompletedFirst Posted
Study publicly available on registry
July 28, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedApril 11, 2019
September 1, 2018
3 years
July 21, 2016
April 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
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 ADPKD-IS score changes
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 ADPKD-Urinary Impact Scale (UIS) score changes
From Baseline to end of study (maximum of 18 months)
Description of real-world ADPKD treatment patterns (number of subjects taking different treatments)
From Baseline to end of study (maximum of 18 months)
- +1 more secondary outcomes
Other Outcomes (2)
Mean ADPKD-Pain and Discomfort Scale(PDS) score change from baseline to end of study (exploratory)
From Baseline to end of study (maximum of 18 months)
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)
At baseline and at the end of the study (18 months)
Eligibility Criteria
The study population will be adult patients with ADPKD in CKD Stages 1 -3, with evidence of rapidly progressing disease according to the investigator. Investigator must be ADPKD experts qualified by experience and ability to perform the study and be working at an ADPKD reference centre.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
Liège, Belgium
Clinique La Louviere
Lille, France
CHU Nimes - Hôpital CAREMEAU
Nîmes, France
Hopital Tenon
Paris, France
Necker Hospital
Paris, France
CHU TOURS - Hôpital Bretonneau
Tours, France
Charite Berlin
Berlin, Germany
Universitätsmedizin Göttingen
Göttingen, Germany
University Medical Center Schleswig-Holstein
Lübeck, Germany
Fundación Puigvert
Barcelona, Spain
Hospital Clinic
Barcelona, Spain
Hospital Vall d'Hebron
Barcelona, Spain
Hospital Universitario de Getafe
Getafe, Spain
University Hospital of Geneve
Geneva, Switzerland
University Hospital of Zurich
Zurich, Switzerland
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, United Kingdom
Related Publications (1)
Joly D, Quinn J, Mokiou S, O'Reilly K, Sanchez-Covisa J, Wang-Silvanto J, Doll H. Rationale and study protocol of ACQUIRE, a prospective, observational study measuring quality of life, treatment preference and treatment satisfaction of autosomal dominant polycystic kidney disease (ADPKD) patients in Europe. BMC Nephrol. 2020 Jul 24;21(1):298. doi: 10.1186/s12882-020-01927-1.
PMID: 32709218DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Department
Otsuka Europe
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2016
First Posted
July 28, 2016
Study Start
October 1, 2016
Primary Completion
October 1, 2019
Study Completion
March 1, 2020
Last Updated
April 11, 2019
Record last verified: 2018-09