Fexofenadine Versus Gabapentin for Uremic Pruritus in Patients on Regular Hemodialysis

Tanta University

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Disease-associated Pruritus; Hemodialysis; ESRD; Renal Replacement Therapy; Uremic Pruritus; End-stage Renal Disease

Treatments: Drug: Fexofenadine; Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT06466421

Fexof vs Gaba for UP in RHD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Group 1: (Gabapentin group)

Active Comparator group

Description:

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.

Treatment:

Drug: Gabapentin

Group 2: (Fexofenadine group)

Experimental group

Description:

30 patients will receive Fexofenadine 60 mg orally once daily for 3 months.

Treatment:

Drug: Fexofenadine