Fexofenadine Versus Gabapentin for Uremic Pruritus in Patients on Regular Hemodialysis

June 13, 2024 updated by: Mohamed Ihab Hosny Mohamed Elfalaha, Tanta University

Clinical Study to Compare The Safety and Possible Efficacy of 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Elgharbia
      • Tanta, Elgharbia, Egypt, 31527

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1: (Gabapentin group)
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.
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.
Experimental: Group 2: (Fexofenadine group)
30 patients will receive Fexofenadine 60 mg orally once daily for 3 months.
Drug: Fexofenadine
Fexofenadine 60 mg orally once daily for 3 months

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Study Chair: Sahar M El-Haggar, PhD, Tanta University
  • Study Director: Ahmed M Hussein, PhD, Helwan University
  • Principal Investigator: Mohamed I Hosney, PharmD, Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

December 20, 2024

Study Registration Dates

First Submitted

June 7, 2024

First Submitted That Met QC Criteria

June 13, 2024

First Posted (Actual)

June 20, 2024

Study Record Updates

Last Update Posted (Actual)

June 20, 2024

Last Update Submitted That Met QC Criteria

June 13, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fexof vs Gaba for UP in RHD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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