Fexofenadine Versus Gabapentin for Uremic Pruritus in Patients on Regular Hemodialysis

Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06466421
• Other study ID #: Fexof vs Gaba for UP in RHD
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 1, 2024
• Est. completion date: December 20, 2024

Study information

• Verified date: June 2024
• Source: Tanta University
• Contact: Mohamed I Elfalaha, PharmD
• Phone: +201020576299
• Email: Phmoehab[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 20, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease-associated Pruritus
• End-stage Renal Disease
• ESRD
• Hemodialysis
• Kidney Diseases
• Kidney Failure, Chronic
• Pruritus
• Renal Insufficiency, Chronic
• Renal Replacement Therapy
• Uremic Pruritus

Intervention

Drug:
• Fexofenadine
Fexofenadine 60 mg orally once daily for 3 months
• 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.

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	Elgharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Visual Analogue Scale (VAS)	The change in mean score of Visual Analogue Scale (VAS) from baseline.	3 months
Primary	Skindex score	The change in mean Skindex score from baseline.	3 months
Primary	Kidney Disease Quality of Life Short Form (KDQOL-SF™)	The change in mean KDQOL-SF score from baseline.	3 months
Secondary	Interleukin-6 (IL-6)	The change in mean serum level of Interleukin-6 (IL-6) from baseline.	3 months
Secondary	Substance P	The change in mean serum level of Substance P from baseline.	3 months