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Uremic PruritusPhase 4NCT06466421

Fexofenadine Versus Gabapentin for Uremic Pruritus in Patients on Regular Hemodialysis

A Phase 4 study testing Fexofenadine and Gabapentin in people with Uremic Pruritus and Chronic Kidney Disease-associated Pruritus, run by Tanta University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Fexofenadine and Gabapentin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
1 Jul 2024to 20 Dec 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Egypt1 site

  • Tanta University

    Tanta, Elgharbia, 31527

Other trials in Egypt

About this study

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

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.

Read the 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.

Being tested
Fexofenadine, Gabapentin
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
Medical subject headings
Kidney Failure, Chronic, Pruritus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FexofenadineDrug

    Fexofenadine 60 mg orally once daily for 3 months

  • GabapentinDrug

    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.

Study groups in NCT06466421
Study groupRoleWhat they receive
Group 1: (Gabapentin group)Active comparator30 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.
Receives: Drug: Gabapentin
Group 2: (Fexofenadine group)Experimental30 patients will receive Fexofenadine 60 mg orally once daily for 3 months.
Receives: Drug: Fexofenadine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Visual Analogue Scale (VAS)

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

    Measured: 3 months

  2. Skindex score

    The change in mean Skindex score from baseline.

    Measured: 3 months

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

    The change in mean KDQOL-SF score from baseline.

    Measured: 3 months

Secondary outcomes (2)

  1. Interleukin-6 (IL-6)

    The change in mean serum level of Interleukin-6 (IL-6) from baseline.

    Measured: 3 months

  2. Substance P

    The change in mean serum level of Substance P from baseline.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2024
  2. Study start1 Jul 2024
  3. Primary completion1 Oct 2024
  4. Study completion20 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06466421
Sponsor's protocol ID
Fexof vs Gaba for UP in RHD
Status last verified
Apr 2025
First submitted
7 Jun 2024
Last updated
27 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30409247

  • 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.

    PubMed 32954065

  • 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.

    PubMed 30975656

  • 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.

    PubMed 22867659

  • 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.

    PubMed 30673107

  • 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.

    PubMed 23530302

  • 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.

    PubMed 25374757

  • 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.

    PubMed 33221158

  • 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.

    PubMed 36506564

  • 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.

    PubMed 29976533

  • 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.

    PubMed 14499429

  • 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.

    PubMed 19995367

  • 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.

    PubMed 30211382

  • 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.

    PubMed 21056479

  • 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.

    PubMed 8875954

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fexofenadine and Gabapentin in people with Uremic Pruritus and Chronic Kidney Disease-associated Pruritus, run by Tanta University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Visual Analogue Scale (VAS) (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06466421, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.

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