Montelukast for Treatment of Uremic Pruritus

Study Overview
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Brief Summary
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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
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Montelukast is an antileukotrien receptor antagonist that seems to be effective as an antipruritic medication via blocking inflammatory pathways.

Official Title
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Assessment of Montelukast Efficacy in the Treatment of Refractive Uremic Pruritus

Conditions
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Renal Insufficiency, Chronic

Intervention / Treatment
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* Drug: Montelukast
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: montelukast<br>montelukast 10 milligram, daily for 30 days | Drug: Montelukast<br> <br> |
| Placebo Comparator: placebo<br>Placebo one tablet for 30 days | Drug: placebo<br>* Placebo (For Montelukast) Placebo pills manufactured for mimic 10 milligram montelukast pills<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Detailed score proposed by Duo for pruritus | Change from Baseline in Detailed score at 1months | Change from Baseline in Detailed score at 1months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Highly sensitive CRP (hs-CRP) | This test is a serologic biochemical test | Change from Baseline in serum value at 1months |