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
About this trial
This is an interventional treatment trial for Renal Insufficiency, Chronic
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
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
NCT ID
NCT02559388
First Posted
September 9, 2015
Last Updated
September 23, 2015
Sponsor
Shiraz University of Medical Sciences
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
Learn more about this trial
Montelukast for Treatment of Uremic Pruritus
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