Montelukast for Treatment of Uremic Pruritus

Not Applicable

Completed

• Conditions: Renal Insufficiency, Chronic
• Interventions: Drug: Montelukast; Drug: placebo

• Registration Number: NCT02559388
• Lead Sponsor: Shiraz University of Medical Sciences

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.

Study Timeline

• Study Start: 2015-04
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-09
• Study First Submitted: 2015-09-09
• Study First Submitted QC: 2015-09-23
• Last Update Submitted: 2015-09-23
• Study First Posted: 2015-09-24
• Last Update Posted: 2015-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
montelukast	Montelukast	montelukast 10 milligram, daily for 30 days
placebo	placebo	Placebo one tablet for 30 days

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Highly sensitive CRP (hs-CRP)	Change from Baseline in serum value at 1months	This test is a serologic biochemical test