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Montelukast for Treatment of Uremic Pruritus

Primary Purpose

Renal Insufficiency, Chronic

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Montelukast
placebo
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Insufficiency, Chronic

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • hemodialysis patients that refered to dialysis centers and at least on hemodialysis thrice weekly
  • presence of uremic pruritus
  • patients that at least had refractive pruritus that lead to sleep disorders or compromised daily activities
  • patients should took a course of antipruritic treatment with no proper response

Exclusion Criteria:

  • presence of pruritus less than three months
  • kt/V less than 1.2
  • presence of pruritus due to other cause other than uremic state
  • presence of other pruritic diseases; malignancies; cholestasis; hepatitis B and C infection
  • treatment with corticosteroid
  • presence of anemia with hemoglobin less than 10

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    montelukast

    placebo

    Arm Description

    montelukast 10 milligram, daily for 30 days

    Placebo one tablet for 30 days

    Outcomes

    Primary Outcome Measures

    Change from Baseline in Detailed score proposed by Duo for pruritus
    Change from Baseline in Detailed score at 1months

    Secondary Outcome Measures

    Highly sensitive CRP (hs-CRP)
    This test is a serologic biochemical test

    Full Information

    First Posted
    September 9, 2015
    Last Updated
    September 23, 2015
    Sponsor
    Shiraz University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02559388
    Brief Title
    Montelukast for Treatment of Uremic Pruritus
    Official Title
    Assessment of Montelukast Efficacy in the Treatment of Refractive Uremic Pruritus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2015 (undefined)
    Primary Completion Date
    August 2015 (Actual)
    Study Completion Date
    August 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shiraz University of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    In this study hemodialysis patients that underwent dialysis thrice weekly screen for uremic pruritus and 80 patients that at least have refractive pruritus that lead to sleep and daily activity disorders enroll in this study. These patients should have at least a course of therapy without proper response. After proper informing patients and taking testimonial patients enter to study. Then patients randomized in case and control group. In case group, patients took montelukast 10 milligram daily and in control group took placebo for 30 days. Other antipruritic or antiinflammatory medication has been stopped one week prior to starting treatment. Calcium, phosphorous, urea, creatinine, highly sensitive CRP (hsCRP), Parathyroid Hormone (PTH), hemoglobin and kt/V were measured at beginning and at end of study. pruritus severity assessed by Detailed Pruritus Score that introduced by Duo and Visual Analogue Score in beginning and at end of study in both group. Sleep disorder score and its severity added to crude score at beginning and end of study and change of measures analyzed.
    Detailed Description
    Montelukast is an antileukotrien receptor antagonist that seems to be effective as an antipruritic medication via blocking inflammatory pathways.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Renal Insufficiency, Chronic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    73 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    montelukast
    Arm Type
    Active Comparator
    Arm Description
    montelukast 10 milligram, daily for 30 days
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo one tablet for 30 days
    Intervention Type
    Drug
    Intervention Name(s)
    Montelukast
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    Placebo (For Montelukast) Placebo pills manufactured for mimic 10 milligram montelukast pills
    Primary Outcome Measure Information:
    Title
    Change from Baseline in Detailed score proposed by Duo for pruritus
    Description
    Change from Baseline in Detailed score at 1months
    Time Frame
    Change from Baseline in Detailed score at 1months
    Secondary Outcome Measure Information:
    Title
    Highly sensitive CRP (hs-CRP)
    Description
    This test is a serologic biochemical test
    Time Frame
    Change from Baseline in serum value at 1months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: hemodialysis patients that refered to dialysis centers and at least on hemodialysis thrice weekly presence of uremic pruritus patients that at least had refractive pruritus that lead to sleep disorders or compromised daily activities patients should took a course of antipruritic treatment with no proper response Exclusion Criteria: presence of pruritus less than three months kt/V less than 1.2 presence of pruritus due to other cause other than uremic state presence of other pruritic diseases; malignancies; cholestasis; hepatitis B and C infection treatment with corticosteroid presence of anemia with hemoglobin less than 10
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohammad Mehdi Sagheb, Professor
    Organizational Affiliation
    Shiraz University of Medical Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    33283264
    Citation
    Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
    Results Reference
    derived

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    Montelukast for Treatment of Uremic Pruritus

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