Montelukast for Treatment of Uremic Pruritus

Shiraz University of Medical Sciences73 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Renal Insufficiency, Chronic

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change from Baseline in Detailed score proposed by Duo for pruritus

Change from Baseline in Detailed score at 1months

Time frame: Change from Baseline in Detailed score at 1months

Secondary Outcomes

Highly sensitive CRP (hs-CRP)

This test is a serologic biochemical test

Time frame: Change from Baseline in serum value at 1months