Fexofenadine Versus Gabapentin for Uremic Pruritus in Patients on Regular Hemodialysis

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.

Timeline

Start

2024-07-01

Primary completion

2024-10-01

Completion

2024-12-20

Publications

• Background Yosipovitch G, Rosen JD, Hashimoto T. Itch: From mechanism to (novel) therapeutic approaches. J Allergy Clin Immunol. 2018 Nov;142(5):1375-1390. doi: 10.1016/j.jaci.2018.09.005.
• 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.
• 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.
• Background 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.
• 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.
• 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.
• 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.
• Background 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.
• 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.
• 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.
• 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.
• 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.
• Background 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.
• Background Davidson S, Giesler GJ. The multiple pathways for itch and their interactions with pain. Trends Neurosci. 2010 Dec;33(12):550-8. doi: 10.1016/j.tins.2010.09.002. Epub 2010 Nov 5.
• 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.
• Background 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.

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Indications