CEP – UK (Clinical Experience of Patiromer in UK)
Research type
Research Study
Full title
CEP – UK (Clinical Experience of Patiromer in UK) A multi-centre, observational study on the early NHS clinical experiences of patiromer in treating hyperkalaemia in patients who receive renin-angiotensin-aldosterone system inhibitors in England and Wales
IRAS ID
241035
Contact name
Kieran McCafferty
Contact email
Sponsor organisation
Vifor Fresenius Medical Care Renal Pharma UK Ltd.
Duration of Study in the UK
1 years, 5 months, 11 days
Research summary
The study aims to assess the effectiveness, adverse events, resource use, patient experience associated with medication called patiromer and describe the clinical characteristics of patients who take it. Patiromer is approved to be prescribed for high potassium levels (hyperkalaemia). Hyperkalaemia is a condition often seen in patients with chronic kidney disease with heart failure and/or type 2 diabetes. High levels of potassium prevent these patients from taking the needed doses of another group of medication called RAASi (Renin-angiotensin-aldosterone system inhibitors), which are needed to slow down the progression of chronic kidney disease. Scientific research shows that patients who do not receive the required doses of RAASi medication or are forced to discontinue it are more likely to have poorer health and are more likely to die. The trials of patiromer showed that patiromer successfully helped to treat high hyperkalaemia in patients who were receiving RAASi medication. Now that the medication is in clinical use, it is important to assess how it affects patients in the real world. This is a multi-centre, observational study of patients in the UK who receive patiromer. It is a single cohort study which will take place in 5-10 NHS secondary care centres with access to patiromer and include approximately 125 patients. Data will be collected from medical records for the 6 months pre- and post-initiation of patiromer, and patient completion of 3 patient reported outcome/experience questionnaires: EQ-5D-3L, the Kansas City Cardiomyopathy Questionnaire (KCCQ) and a bespoke study questionnaire. These will be completed at initiation of patiromer and approx 3 and 6 months later.
REC name
London - Queen Square Research Ethics Committee
REC reference
18/LO/0148
Date of REC Opinion
19 Feb 2018
REC opinion
Further Information Favourable Opinion