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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.
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
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Mean ADPKD-IS score changes |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Department | Otsuka Europe | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AKH Wien | Vienna | Austria | ||||
| LKH Villach |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32709218 | Derived | 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. |
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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) |
| 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) |
| 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) |
| Description of real-world ADPKD treatment patterns (number of subjects taking different treatments) | From Baseline to end of study (maximum of 18 months) |
| Description of real-world ADPKD treatment patterns (percentage of subjects taking different treatments) | 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) | 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) |
| 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 |
| ID | Term |
|---|---|
| D016891 | Polycystic Kidney, Autosomal Dominant |
| ID | Term |
|---|---|
| D007690 | Polycystic Kidney Diseases |
| D052177 | Kidney Diseases, Cystic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000072661 | Ciliopathies |
| D030342 | Genetic Diseases, Inborn |
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