Data category | Information |
---|---|
Primary registry and trial identifying number | |
Date of registration in primary registry | July 21, 2016 |
Secondary identifying numbers | 156–303-00096 |
Source(s) of monetary or material support | Otsuka Pharmaceutical Europe Ltd |
Primary sponsor | Otsuka Pharmaceutical Europe Ltd |
Secondary sponsor(s) | N/A |
Contact for public queries | Study Director, Medical Department Otsuka EuropeTel: + 44 (0) 2037475000 |
Contact for scientific queries | Study Director, Medical Department Otsuka EuropeTel: + 44 (0) 2037475000 |
Public title | A Study Measuring Quality of Life, Treatment Preference and Satisfaction of ADPKD Patients in Europe |
Scientific title | A Prospective, Non-interventional Study Measuring Quality of Life, Treatment Preference and Treatment Satisfaction of Autosomal Dominant Polycystic Kidney Disease Patients in Europe |
Countries of recruitment | Austria, Belgium, France, Germany, Spain, Switzerland, United Kingdom |
Health condition(s) or problem(s) studied | Autosomal Dominant Polycystic Kidney Disease |
Intervention(s) | N/A – this is a non-interventional study |
Key inclusion and exclusion criteria |
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 type | Observational |
Date of first enrolment | October 2016 |
Target sample size | 486 |
Recruitment status | Active, not recruiting |
Primary outcome(s) | 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. |
Key secondary outcomes | 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-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 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-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). 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) 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) from baseline to end of study, in the overall sample and per CKD stage |
Open Access 01.12.2020 | Study protocol
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
Erschienen in: BMC Nephrology | Ausgabe 1/2020