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.

Phase 2

Recruiting

• Conditions: raemic pruritis; End Stage Kidney Disease (ESKD); Uraemic pruritis; Renal and Urogenital - Kidney disease; Skin - Other skin conditions

• Registration Number: ACTRN12621001626853
• Lead Sponsor: niversity of Technology Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-29
• Last Update Posted: 29 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

18 years of age or more.
CKD 5 (eGFR<15) or CKD 4 (eGFR 15 -30)
Moderate to severe uraemic pruritus (WI-NRS=3) and chronic itch (> 6 weeks)
Able to read study questionnaires (5th grade level) in English.
Able to provide fully informed written consent
Capable of completing assessments, study diary and complying with the study procedures

Exclusion Criteria

Itch not related to uraemic pruritus (as determined by a clinician). i.e. itch related to dermatological conditions, liver failure or cholestatic pruritus, neurological (post-herpetic neuralgia) and psychogenic disease.
Suicidality item in MADRS score >4
Known allergy or previous intolerance to Gabapentinoids (Pregabalin and Gabapentin).
Use of Gabapentinoids within the last 2 weeks.
High phosphate (PO4>2.5), corrected calcium (Ca2+>2.7) and low haemoglobin (Hb <80), Serum Iron (Fe2+>4)
Anuria
Clinician predicted survival less than one month
Pregnant or breastfeeding
Chronic alcoholism or drug abuse
Australian-modified Karnofsky performance score (AKPS) less than 50 at the beginning of the study
Participated in a clinical study of a new chemical entity within the month prior to study randomization

Study & Design

• Study Type: Interventional
• Study Design: Not specified