Clinical trial

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

Name

Fexof vs Gaba for UP in RHD

Description

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.

Trial arms

Trial start

2024-07-01

Estimated PCD

2024-10-01

Trial end

2024-12-20

Status

Not yet recruiting

Phase

Early phase I

Treatment

Fexofenadine

Fexofenadine 60 mg orally once daily for 3 months

Arms:

Group 2: (Fexofenadine group)

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.

Arms:

Group 1: (Gabapentin group)

Size

Primary endpoint

The Visual Analogue Scale (VAS)

3 months

Skindex score

3 months

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

3 months

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2024-06-19

1 organization

2 products

6 indications

Organization

Tanta University

Product

Fexofenadine

Indication

Uremic Pruritus

Indication