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

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ClinicalTrials.gov Identifier: NCT02848521
Recruitment Status : Active, not recruiting
First Posted : July 28, 2016
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Autosomal Dominant Polycystic Kidney Disease

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

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Study Type : Observational
Actual Enrollment : 407 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : October 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases




Primary Outcome Measures :
  1. Mean rate of change (%) in Physical Health Composite Scale (PCS) scores of the 12-Item Short Form Survey (SF-12) [ Time Frame: 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 :
  1. Mean rate of change (%) in Mental Health Composite Scale (MCS) scores of the SF-12 [ Time Frame: 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.

  2. Mean ADPKD-IS score changes [ Time Frame: 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).

  3. Mean Treatment Satisfaction Questionnaire for Medication (TSQM-9) score changes [ Time Frame: 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).

  4. Mean ADPKD-Urinary Impact Scale (UIS) score changes [ Time Frame: 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).

  5. Description of real-world ADPKD treatment patterns (number of subjects taking different treatments) [ Time Frame: From Baseline to end of study (maximum of 18 months) ]
  6. Description of real-world ADPKD treatment patterns (percentage of subjects taking different treatments) [ Time Frame: From Baseline to end of study (maximum of 18 months) ]

Other Outcome Measures:
  1. Mean ADPKD-Pain and Discomfort Scale(PDS) score change from baseline to end of study (exploratory) [ Time Frame: From Baseline to end of study (maximum of 18 months) ]
    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)

  2. 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) [ Time Frame: At baseline and at the end of the study (18 months) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848521


Locations
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Austria
AKH Wien
Vienna, Austria
LKH Villach
Villach, Austria
Belgium
UCL Brussels
Brussels, Belgium
UZ Brussels
Brussels, Belgium
UZ Leuven/Gasthuisberg KUL
Leuven, Belgium
CHU Liège - Domaine Universitaire du Sart Tilman
Liege, Belgium
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, France
Germany
Charite Berlin
Berlin, Germany
Universitätsmedizin Göttingen
Gottingen, Germany
University Medical Center Schleswig-Holstein
Lubeck, Germany
Spain
Fundación Puigvert
Barcelona, Spain
Hospital Clinic
Barcelona, Spain
Hospital Vall d'Hebron
Barcelona, Spain
Hospital Universitario de Getafe
Getafe, Spain
Switzerland
University Hospital of Geneve
Genève, Switzerland
University Hospital of Zurich
Zürich, Switzerland
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, United Kingdom
Sponsors and Collaborators
Otsuka Pharmaceutical Europe Ltd
Investigators
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Study Director: Medical Department Otsuka Europe

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Responsible Party: Otsuka Pharmaceutical Europe Ltd
ClinicalTrials.gov Identifier: NCT02848521     History of Changes
Other Study ID Numbers: 156-303-00096
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: September 2018
Keywords provided by Otsuka Pharmaceutical Europe Ltd:
ADPKD
CKD
Rapid progressor
quality of life
DCE
Additional relevant MeSH terms:
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Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic
Abnormalities, Multiple
Congenital Abnormalities
Ciliopathies
Genetic Diseases, Inborn