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

April 9, 2019 updated by: Otsuka Pharmaceutical Europe Ltd

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
407

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From Baseline to end of study (maximum of 18 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
From Baseline to end of study (maximum of 18 months)
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).
From Baseline to end of study (maximum of 18 months)
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).
From Baseline to end of study (maximum of 18 months)
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).
From Baseline to end of study (maximum of 18 months)
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)
From Baseline to end of study (maximum of 18 months)
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)
From Baseline to end of study (maximum of 18 months)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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)
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.
At baseline and at the end of the study (18 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Otsuka Pharmaceutical Europe Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2016

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 156-303-00096

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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