#3142 Evaluation of antipruritic effect of tacrolimus on hemodialysis patients with uremic pruritus, a double-blind, randomized, clinical trial

Abstract

Abstract Background and Aims Pruritus in patients undergoing hemodialysis is a highly prevalent complication that affects quality of life. Several medications are currently used for the treatment of uremic pruritus, but these are not satisfactory. There are few studies about the beneficial effect of oral Tacrolimus on dermatologic problems such as pruritus. Considering the condition of hemodialysis in ESKD patients and the probable presence of oral Tacrolimus in their future treatment plan, this trial is designed to assess the antipruritic effect of Tacrolimus compared with placebo. Method This multicenter, randomized, double-blind, placebo-controlled clinical trial included 75 patients undergoing hemodialysis. The patients were randomized to a treatment group (Tacrolimus 1 mg/day) or a control group (placebo). The treatment lasted eight weeks, followed by a 2-week observational period. Visual Analogue Scale (VAS), % affected Body Surface Area (%BSA), and 12-Pruritus Severity Scale questionnaire (12-PSS) were measured before and after treatment periods. Moreover, sleep quality and the effect of sex were also evaluated. Results Seventy-five patients under hemodialysis (mean age of 58.18 ± 09.39 years) completed the study. Mean changes in VAS, %BSA, and 12-PSS after the interventions (Tacrolimus vs. placebo, mean ± SD) were as follows, respectively: −3.77 ± 2.13 vs. −1.07 ± 1.17, −18.97 ± 12.20 vs. 2.44 ± 3.23, and −4.67 ± 3.21 vs. −1.32 ± 2.45 (P < 0.0001). An improvement in sleep quality was found in 52.6% (20/38) of patients after Tacrolimus intake (P < 0.01). Overall, Tacrolimus was more effective in women than men (P < 0.016). Conclusion Based on the preliminary results of this study, Tacrolimus can be introduced as an effective drug for the management of pruritus and can be an add-on therapy in uremic patients.