ACTRN12621001626853
Recruiting
Phase 2
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.
niversity of Technology Sydney0 sites24 target enrollmentNovember 29, 2021
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Technology Sydney
- Enrollment
- 24
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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\)
- •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
Outcomes
Primary Outcomes
Not specified
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