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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06466421

Enrollment

Registered

2024-06-20

Start date

2024-07-01

Completion date

2024-12-20

Last updated

2025-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

pruritus, Hemodialysis, ESRD, RHD, Fexofenadine, Gabapentin, Interleukin 6, IL-6, Substance P, SP, CKD-aP, Chronic Kidney Disease-associated Pruritus, Uremic, UP, Uremic Pruritus, End-stage Renal Disease

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.

Interventions

DRUGFexofenadine

Fexofenadine 60 mg orally once daily for 3 months

DRUGGabapentin

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.
Kidney Disease Quality of Life Short Form (KDQOL-SF™)	3 months	The change in mean KDQOL-SF score from baseline.

Secondary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026