Fexofenadine Versus Gabapentin for Uremic Pruritus in Patients on Regular Hemodialysis

NCT06466421 | Completed Phase 4 DMC

• 1 other identifier: Fexof vs Gaba for UP in RHD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• The Visual Analogue Scale (VAS)

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

  3 months

• Skindex score

  The change in mean Skindex score from baseline.

  3 months

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

  The change in mean KDQOL-SF score from baseline.

  3 months

Secondary Outcomes (2)

• Interleukin-6 (IL-6)

  3 months

• Substance P

  3 months

Study Arms (2)

Group 1: (Gabapentin group)

ACTIVE COMPARATOR

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

Group 2: (Fexofenadine group)

EXPERIMENTAL

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

Drug: Fexofenadine

Interventions

Fexofenadine DRUG

Fexofenadine 60 mg orally once daily for 3 months

Group 2: (Fexofenadine group)

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.

Group 1: (Gabapentin group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Elgharbia, 31527, Egypt

Location

Related Publications (16)

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  PMID: 30409247 BACKGROUND

• Verduzco HA, Shirazian S. CKD-Associated Pruritus: New Insights Into Diagnosis, Pathogenesis, and Management. Kidney Int Rep. 2020 May 8;5(9):1387-1402. doi: 10.1016/j.ekir.2020.04.027. eCollection 2020 Sep.

  PMID: 32954065 BACKGROUND

• Sukul N, Speyer E, Tu C, Bieber BA, Li Y, Lopes AA, Asahi K, Mariani L, Laville M, Rayner HC, Stengel B, Robinson BM, Pisoni RL; CKDopps and CKD-REIN investigators. Pruritus and Patient Reported Outcomes in Non-Dialysis CKD. Clin J Am Soc Nephrol. 2019 May 7;14(5):673-681. doi: 10.2215/CJN.09600818. Epub 2019 Apr 11.

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• Smith BH, Higgins C, Baldacchino A, Kidd B, Bannister J. Substance misuse of gabapentin. Br J Gen Pract. 2012 Aug;62(601):406-7. doi: 10.3399/bjgp12X653516. No abstract available.

  PMID: 22867659 BACKGROUND

• Schricker S, Heider T, Schanz M, Dippon J, Alscher MD, Weiss H, Mettang T, Kimmel M. Strong Associations Between Inflammation, Pruritus and Mental Health in Dialysis Patients. Acta Derm Venereol. 2019 May 1;99(6):524-529. doi: 10.2340/00015555-3128.

  PMID: 30673107 BACKGROUND

• Ricardo AC, Hacker E, Lora CM, Ackerson L, DeSalvo KB, Go A, Kusek JW, Nessel L, Ojo A, Townsend RR, Xie D, Ferrans CE, Lash JP; CRIC Investigators. Validation of the Kidney Disease Quality of Life Short Form 36 (KDQOL-36) US Spanish and English versions in a cohort of Hispanics with chronic kidney disease. Ethn Dis. 2013 Spring;23(2):202-9.

  PMID: 23530302 BACKGROUND

• Park IH, Um JY, Cho JS, Lee SH, Lee SH, Lee HM. Histamine Promotes the Release of Interleukin-6 via the H1R/p38 and NF-kappaB Pathways in Nasal Fibroblasts. Allergy Asthma Immunol Res. 2014 Nov;6(6):567-72. doi: 10.4168/aair.2014.6.6.567. Epub 2014 Jul 28.

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• Oweis AO, Al-Qarqaz F, Bodoor K, Heis L, Alfaqih MA, Almomani R, Obeidat MA, Alshelleh SA. Elevated interleukin 31 serum levels in hemodialysis patients are associated with uremic pruritus. Cytokine. 2021 Feb;138:155369. doi: 10.1016/j.cyto.2020.155369. Epub 2020 Nov 19.

  PMID: 33221158 BACKGROUND

• Oh G, Moga DC, Fardo DW, Abner EL. The association of gabapentin initiation and neurocognitive changes in older adults with normal cognition. Front Pharmacol. 2022 Nov 25;13:910719. doi: 10.3389/fphar.2022.910719. eCollection 2022.

  PMID: 36506564 BACKGROUND

• Gobo-Oliveira M, Pigari VG, Ogata MS, Miot HA, Ponce D, Abbade LP. Gabapentin versus dexchlorpheniramine as treatment for uremic pruritus: a randomised controlled trial. Eur J Dermatol. 2018 Aug 1;28(4):488-495. doi: 10.1684/ejd.2018.3356.

  PMID: 29976533 BACKGROUND

• Fehrenbacher JC, Taylor CP, Vasko MR. Pregabalin and gabapentin reduce release of substance P and CGRP from rat spinal tissues only after inflammation or activation of protein kinase C. Pain. 2003 Sep;105(1-2):133-41. doi: 10.1016/s0304-3959(03)00173-8.

  PMID: 14499429 BACKGROUND

• Elman S, Hynan LS, Gabriel V, Mayo MJ. The 5-D itch scale: a new measure of pruritus. Br J Dermatol. 2010 Mar;162(3):587-93. doi: 10.1111/j.1365-2133.2009.09586.x. Epub 2009 Dec 1.

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• Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.

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  PMID: 21056479 BACKGROUND

• Chren MM, Lasek RJ, Quinn LM, Mostow EN, Zyzanski SJ. Skindex, a quality-of-life measure for patients with skin disease: reliability, validity, and responsiveness. J Invest Dermatol. 1996 Nov;107(5):707-13. doi: 10.1111/1523-1747.ep12365600.

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• Ningombam A, Handa S, Srivastava N, Mahajan R, De D. Addition of oral fexofenadine to topical therapy leads to a significantly greater reduction in the serum interleukin-31 levels in mild to moderate paediatric atopic dermatitis. Clin Exp Dermatol. 2022 Apr;47(4):724-729. doi: 10.1111/ced.15032. Epub 2022 Jan 6.

  PMID: 34826148 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Pruritus

Interventions

fexofenadine; Gabapentin

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Sahar M El-Haggar, PhD

  Tanta University

  STUDY CHAIR

• Ahmed M Hussein, PhD

  Helwan University

  STUDY DIRECTOR

• Mohamed I Hosney, PharmD

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacist

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 20, 2024
• Study Start: July 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 20, 2024
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)