A Phase II, prospective, open-label, dual-centre, single-arm feasibility study of Pregabalin for the management of uraemic pruritus in patients with End Stage Kidney Disease (ESKD) who are conservatively managed.

Itch is a common and disabling symptom for people living with advanced kidney disease (termed Uraemic Pruritus (UP)). It causes skin irritation and bleeding, disrupts sleep, is associated with mood changes (depression) and often indicates a shortened survival. As many as 75% of patients, who are not receiving dialysis, suffer from UP. The cause of UP currently remains poorly understood. Pregabalin is a medication which acts by desensitizing peripheral nerve fibers, which leads to a reduction of the itch sensation. It is an emerging drug that is becoming more commonly used in clinical practice to treat UP. However, current evidence is weak, and further research is required to definitely confirm the benefit of this medication. This proposed Phase 2 Feasibility Study is an open-label, single arm, dose up-titration study that is looking at Pregabalin efficacy and tolerability in treating patients with moderate to severe UP who are being conservatively treated for End Stage Renal Failure (ESRF) (eGFR<30, CKD 4 and 5). The primary outcome measure is to recruit at least 24 patients over a 12 month period at both Liverpool and St George Hospitals. It is a 12 week study with the primary outcome measure at Week 4 which specifically looks at a Retention rate of >60. It is important to note that both hospitals contain large culturally and linguistically diverse (CALD) populations. The results of this Phase 2 study will be used to design a subsequent Phase 3 study that will specifically look at the effectiveness of Pregabalin for the treatment of UP and may facilitate access to the medication through subsidised means, if found to be effective.