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NCT Number: NCT06466421

Fexofenadine Versus Gabapentin for Uremic Pruritus in Patients on Regular Hemodialysis

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.

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Key information

Conditions

Uremic Pruritus Chronic Disease Chronic Kidney Disease-associated Pruritus Disease Attributes ESRD End-stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemodialysis Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pruritus Renal Insufficiency Renal Insufficiency, Chronic Renal Replacement Therapy Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tanta University

Tanta, Elgharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fexofenadine

Drug

Fexofenadine 60 mg orally once daily for 3 months

Gabapentin

Drug

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 outcomes

  1. The Visual Analogue Scale (VAS)

    Time frame: 3 months

    The change in mean score of Visual Analogue Scale (VAS) from baseline.

  2. Skindex score

    Time frame: 3 months

    The change in mean Skindex score from baseline.

  3. Kidney Disease Quality of Life Short Form (KDQOL-SF™)

    Time frame: 3 months

    The change in mean KDQOL-SF score from baseline.

Secondary outcomes

  1. Interleukin-6 (IL-6)

    Time frame: 3 months

    The change in mean serum level of Interleukin-6 (IL-6) from baseline.

  2. Substance P

    Time frame: 3 months

    The change in mean serum level of Substance P from baseline.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 20, 2024
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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