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

NCT ID: NCT02848521

Last Updated: 2019-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

407 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2020-03-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Autosomal Dominant Polycystic Kidney Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka Pharmaceutical Europe Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Department

Role: STUDY_DIRECTOR

Otsuka Europe

Locations

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AKH Wien

Vienna, , Austria

Site Status

LKH Villach

Villach, , Austria

Site Status

UCL Brussels

Brussels, , Belgium

Site Status

UZ Brussels

Brussels, , Belgium

Site Status

UZ Leuven/Gasthuisberg KUL

Leuven, , Belgium

Site Status

CHU Liège - Domaine Universitaire du Sart Tilman

Liège, , Belgium

Site Status

Clinique La Louviere

Lille, , France

Site Status

CHU Nimes - Hôpital CAREMEAU

Nîmes, , France

Site Status

Hopital Tenon

Paris, , France

Site Status

Necker Hospital

Paris, , France

Site Status

CHU TOURS - Hôpital Bretonneau

Tours, , France

Site Status

Charite Berlin

Berlin, , Germany

Site Status

Universitätsmedizin Göttingen

Göttingen, , Germany

Site Status

University Medical Center Schleswig-Holstein

Lübeck, , Germany

Site Status

Fundación Puigvert

Barcelona, , Spain

Site Status

Hospital Clinic

Barcelona, , Spain

Site Status

Hospital Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital Universitario de Getafe

Getafe, , Spain

Site Status

University Hospital of Geneve

Geneva, , Switzerland

Site Status

University Hospital of Zurich

Zurich, , Switzerland

Site Status

Edinburgh Royal Infirmary

Edinburgh, , United Kingdom

Site Status

Queen Elizabeth University Hospital

Glasgow, , United Kingdom

Site Status

Aintree University Hospital

Liverpool, , United Kingdom

Site Status

Royal Free Hospital

London, , United Kingdom

Site Status

Royal London Hospital

London, , United Kingdom

Site Status

Freeman Hospital

Newcastle, , United Kingdom

Site Status

Countries

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Austria Belgium France Germany Spain Switzerland United Kingdom

References

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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.

Reference Type DERIVED
PMID: 32709218 (View on PubMed)

Other Identifiers

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156-303-00096

Identifier Type: -

Identifier Source: org_study_id

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