Several studies investigated the effectiveness of Gabapentin in Uremic Pruritus (UP). No previous studies investigated the use of fexofenadine in UP. The aim of this trial is to assess the safety and possible efficacy of fexofenadine in patients with UP.
A randomized controlled single center parallel study, that will recruit 60 participants with end stage renal disease (ESRD) on regular hemodialysis (RHD) with uremic pruritus (UP). Patients will be randomized to either Fexofenadine (60 mg orally once daily), or Gabapentin (100 mg orally after each dialysis session, "thrice weekly", with titration according to response to 100 mg orally once daily). Participants will continue treatment for 3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Fexofenadine 60 mg orally once daily for 3 months
100 mg after each dialysis session (thrice weekly). Dose may be titrated after 2 weeks, according to response and tolerability, to 100 mg orally once daily for 3 months.
Tanta University
Tanta, Elgharbia, Egypt
The Visual Analogue Scale (VAS)
The change in mean score of Visual Analogue Scale (VAS) from baseline.
Time frame: 3 months
Skindex score
The change in mean Skindex score from baseline.
Time frame: 3 months
Kidney Disease Quality of Life Short Form (KDQOL-SF™)
The change in mean KDQOL-SF score from baseline.
Time frame: 3 months
Interleukin-6 (IL-6)
The change in mean serum level of Interleukin-6 (IL-6) from baseline.
Time frame: 3 months
Substance P
The change in mean serum level of Substance P from baseline.
Time frame: 3 months
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