Autosomal Dominant Polycystic Kidney DiseaseACQUIRENCT02848521
A Study Measuring Quality of Life, Treatment Preference and Satisfaction of ADPKD Patients in Europe
An observational study of Autosomal Dominant Polycystic Kidney Disease, run by Otsuka Pharmaceutical Europe Ltd at 26 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney Disease
- How many people
- 407 participants
- Where
- 26 sitesin 7 countries
- Study dates
- Oct 2016to Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
26 sites in 7 countries.
26 sites in 7 countries
United Kingdom6 sites
Edinburgh Royal Infirmary
Edinburgh
Queen Elizabeth University Hospital
Glasgow
Aintree University Hospital
Liverpool
Royal Free Hospital
London
Royal London Hospital
London
Freeman Hospital
Newcastle
France5 sites
Clinique La Louviere
Lille
CHU Nimes - Hôpital CAREMEAU
Nîmes
Hopital Tenon
Paris
Necker Hospital
Paris
CHU TOURS - Hôpital Bretonneau
Tours
Belgium4 sites
UCL Brussels
Brussels
UZ Brussels
Brussels
UZ Leuven/Gasthuisberg KUL
Leuven
CHU Liège - Domaine Universitaire du Sart Tilman
Liège
Spain4 sites
Fundación Puigvert
Barcelona
Hospital Clinic
Barcelona
Hospital Vall d'Hebron
Barcelona
Hospital Universitario de Getafe
Getafe
Germany3 sites
Charite Berlin
Berlin
Universitätsmedizin Göttingen
Göttingen
University Medical Center Schleswig-Holstein
Lübeck
Switzerland2 sites
University Hospital of Geneve
Geneva
University Hospital of Zurich
Zurich
About this study
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
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.
Read the 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
- Keywords
- ADPKD, CKD, Rapid progressor, quality of life, DCE
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: From Baseline to end of study (maximum of 18 months)
Mean ADPKD-IS score changes
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).
Measured: 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).
Measured: 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).
Measured: From Baseline to end of study (maximum of 18 months)
Description of real-world ADPKD treatment patterns (number of subjects taking different treatments)
Measured: From Baseline to end of study (maximum of 18 months)
Description of real-world ADPKD treatment patterns (percentage of subjects taking different treatments)
Measured: From Baseline to end of study (maximum of 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autosomal Dominant Polycystic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Europe Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Department, Study director, Otsuka Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848521
- Sponsor's protocol ID
- 156-303-00096
- Acronym
- ACQUIRE
- Status last verified
- Sep 2018
- First submitted
- 21 Jul 2016
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32709218
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02848521
- Acronym / sponsor ID
- ACQUIRE / 156-303-00096
- Keywords
- ADPKD, CKD, Rapid progressor, quality of life, DCE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 407 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Europe LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 28 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
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 ADPKD-IS score changes
Time frame: 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 ADPKD-Urinary Impact Scale (UIS) score changes
Time frame: 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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- Derived from this study: PubMed 32709218Joly 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.
Related trials for Autosomal Dominant Polycystic Kidney Disease
RecruitingObservational study
Hypertension in Children and Young People at Risk of Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney Disease (ADPKD
Active, not recruitingObservational study
Role of ROS and cAMP-PKA Biomarkers in ADPKD
Autosomal Dominant Polycystic Kidney Disease
Not yet recruitingPhase 1
A Study to Investigate the Pharmacokinetics of JMKX003142 in Healthy Participants and Participants With Hepatic Impairment
ADPKD (Autosomal Dominant Polycystic Kidney Disease), Renal Edema
RecruitingPhase 1
Absorption, Distribution, Metabolism, and Excretion of 14C-VX-407 After a Single Oral Dose
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Department study director
Otsuka Europe
26 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autosomal Dominant Polycystic Kidney Disease, run by Otsuka Pharmaceutical Europe Ltd at 26 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United Kingdom, France, Belgium, Spain, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02848521, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.