Fexofenadine Versus Gabapentin for Uremic Pruritus in Patients on Regular Hemodialysis

Phase 4

Completed

• Conditions: Hemodialysis; End-stage Renal Disease; Uremic Pruritus; Chronic Kidney Disease-associated Pruritus; Renal Replacement Therapy; ESRD
• Interventions: Drug: Fexofenadine; Drug: Gabapentin

• Registration Number: NCT06466421
• Lead Sponsor: Tanta University

Brief 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.

Study Timeline

• Study First Submitted: 2024-06-07
• Study First Submitted QC: 2024-06-13
• Study First Posted: 2024-06-20
• Study Start: 2024-07-01
• Primary Completion: 2024-10-01
• Study Completion: 2024-12-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age ≥ 18 years old.
• ESRD on regular hemodialysis.
• Moderate and severe Uremic Pruritus as assessed by Visual Analogue Scale.
• Able to provide an informed consent.

Exclusion Criteria

• Age < 18 years old.
• Patients not on regular hemodialysis.
• Pruritus due to other cause.
• Cancer patients.
• Pregnancy or breastfeeding.
• Patients with history of substance abuse.
• Patients with myasthenia gravis.
• Patients who refuse or are unable to provide an informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: (Fexofenadine group)	Fexofenadine	30 patients will receive Fexofenadine 60 mg orally once daily for 3 months.
Group 1: (Gabapentin group)	Gabapentin	30 patients will receive 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.

Primary Outcome Measures

Name	Time	Method
Kidney Disease Quality of Life Short Form (KDQOL-SF™)	3 months	The change in mean KDQOL-SF score from baseline.
The Visual Analogue Scale (VAS)	3 months	The change in mean score of Visual Analogue Scale (VAS) from baseline.
Skindex score	3 months	The change in mean Skindex score from baseline.

Secondary Outcome Measures

Name	Time	Method
Substance P	3 months	The change in mean serum level of Substance P from baseline.
Interleukin-6 (IL-6)	3 months	The change in mean serum level of Interleukin-6 (IL-6) from baseline.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, Elgharbia, Egypt