PARADIGM
Research type
Research Study
Full title
The PAn-european Registry Addressing Difelikefalin In Goal-oriented Medical treatment for dialysis-related pruritus study
IRAS ID
353002
Contact name
James Burton
Contact email
Sponsor organisation
Arbor Research Collaborative for Health
Duration of Study in the UK
3 years, 0 months, 31 days
Research summary
Chronic Kidney Disease-associated pruritus (CKD-aP) is a common and debilitating condition affecting patients with kidney failure undergoing haemodialysis (HD). It causes intense itching that can severely impact quality of life, leading to sleep disturbances, depression, and even higher hospitalisation and mortality rates. Despite affecting 40-60% of HD patients, CKD-aP is often under-recognised and has limited treatment options. The exact causes are not fully understood, but they likely involve a build-up of toxins, inflammation, and nerve system changes.
Currently, treatment includes moisturisers, antihistamines, corticosteroids, and medications like gabapentinoids or opioids. However, these provide only partial relief. Difelikefalin (DFK) is the first approved medication specifically for CKD-aP, available in the US (as Korsuva) and Europe (as Kapruvia) since 2021. Previous clinical trials showed that DFK significantly reduced itching, improved sleep, and enhanced overall well-being. Most side effects reported in these trials were mild and temporary.
Although these trials proved DFK’s effectiveness, real-world data is still limited. More research is needed to understand how DFK works in everyday clinical practice, including dosing patterns, side effects, and long-term safety. Additionally, little is known about how CKD-aP treatments affect hospital visits and overall healthcare use.
This study aims to address these gaps by creating a patient registry to track HD patients starting DFK. Over 12+ months, researchers will collect data on treatment decisions, medication changes, side effects, and healthcare usage.
The findings will help optimise DFK’s use, improve patient care, and inform future treatment strategies. Ultimately, this study will provide valuable insights into CKD-aP management, helping both patients and healthcare providers make better treatment decisions.
REC name
London - South East Research Ethics Committee
REC reference
25/PR/1211
Date of REC Opinion
10 Sep 2025
REC opinion
Favourable Opinion