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

Otsuka

Status: Unknown

Conditions: Autosomal Dominant Polycystic Kidney Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT02848521

156-303-00096

Details and patient eligibility

About

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.

Full 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

Enrollment: 407 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.