Clinical trial NCT06466421: Fexofenadine Versus Gabapentin for Uremic Pruritus in Patients on Regular Hemodialysis
Official title: Clinical Study to Compare The Safety and Possible Efficacy of Fexofenadine Versus Gabapentin for Uremic Pruritus in Patients on Regular Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Uremic Pruritus
Chronic Kidney Disease-associated Pruritus
Hemodialysis
End-stage Renal Disease
Renal Replacement Therapy
ESRD
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
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 \&lt; 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.

Primary outcomes:
measure: The Visual Analogue Scale (VAS)
timeFrame: 3 months
measure: Skindex score
timeFrame: 3 months
measure: Kidney Disease Quality of Life Short Form (KDQOL-SF™)
timeFrame: 3 months
Secondary outcomes:
measure: Interleukin-6 (IL-6)
timeFrame: 3 months
measure: Substance P
timeFrame: 3 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: Elgharbia
Study officials:
affiliation: Tanta University
name: Sahar M El-Haggar, PhD
role: STUDY_CHAIR
affiliation: Helwan University
name: Ahmed M Hussein, PhD
role: STUDY_DIRECTOR
affiliation: Tanta University
name: Mohamed I Hosney, PharmD
role: PRINCIPAL_INVESTIGATOR
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