NCT06466421

Fexofenadine Versus Gabapentin for Uremic Pruritus in Patients on Regular Hemodialysis

Clinical Study to Compare The Safety and Possible Efficacy of Fexofenadine Versus Gabapentin for Uremic Pruritus in Patients on Regular Hemodialysis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Uremic Pruritus
• Chronic Kidney Disease-associated Pruritus
• Hemodialysis
• End-stage Renal Disease
• Renal Replacement Therapy
• ESRD

Interventions

Type	Name	Description
DRUG	Fexofenadine	Fexofenadine 60 mg orally once daily for 3 months
DRUG	Gabapentin	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.

Timeline

• Start date: 2024-07-01
• Primary completion: 2024-10-01
• Completion: 2024-12-20
• First posted: 2024-06-20
• Last updated: 2025-04-27

Locations

1 site across 1 country: Egypt