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

Otsuka Pharmaceutical Europe Ltd407 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

407

Conditions

Autosomal Dominant Polycystic Kidney Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (26)

AKH Wien

Vienna, Austria

LKH Villach

Outcomes

Primary Outcomes

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.