Otsuka non-interventional: Quality of life of ADPKD patients
Research type
Research Study
Full title
A prospective, non-interventional study measuring quality of life, patient choice, and treatment satisfaction of Autosomal Dominant Polycystic Kidney Disease patients in Europe.
IRAS ID
204090
Contact name
Christopher Wong
Contact email
Sponsor organisation
Otsuka Pharmaceutical Europe Ltd.
Clinicaltrials.gov Identifier
TFS Internal study number, OTS0001
Duration of Study in the UK
2 years, 1 months, 1 days
Research summary
The reason for this study is to measure and describe the impact autosomal dominant polycystic kidney disease (ADPKD) has on a patient’s quality of life in patients with ADPKD, in stage 1-3 chronic kidney disease (CKD) and with evidence of rapidly progressing disease.
The study will take place in approximately 8 countries in Europe, with the aim of recruiting 486 patients.
Autosomal dominant polycystic kidney disease (ADPKD) is an inherited condition that causes small, fluid-filled sacs called cysts to develop in the kidneys. Patients suffer from symptoms including pain, hypertension, bladder and kidney infections, blood in urine and cyst-related complications. Due to this, the medical resource for patients is very high. Additionally, ADPKD patients have dramatically reduced health-related quality of life (HRQoL).
Researchers believe that a better understanding of the impact ADPKD has on a patient’s quality of life is necessary in the early stages (1-3) of CKD and will be useful in providing measures for disease progression and provide a better, more personalised therapy to these and/or other patients.
The study will measure and describe quality of life in these patients through patient reported outcomes (PROS), which are questionnaires used in a clinical setting where the responses are collected directly from the patient.
There a 6 PROS used in this study, which include general health related quality of life questions, treatment satisfaction, treatment preference, impact of clinical symptoms and clinical outcomes.Patients will be asked to complete the PROs every three months for a maximum of 18 months.
The study is observational and, consequently, all treatment decisions are at discretion of the patient’s health care provider and are not mandated by study design or protocol.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
16/NW/0567
Date of REC Opinion
21 Jul 2016
REC opinion
Favourable Opinion