Montelukast for Treatment of Uremic Pruritus

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.

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Key information

Conditions

Renal Insufficiency, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Montelukast

Drug

Placebo

Drug

Placebo (For Montelukast) Placebo pills manufactured for mimic 10 milligram montelukast pills

Primary outcomes

Change from Baseline in Detailed score proposed by Duo for pruritus

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

Change from Baseline in Detailed score at 1months

Secondary outcomes

Highly sensitive CRP (hs-CRP)

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

This test is a serologic biochemical test

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Official study title

Assessment of Montelukast Efficacy in the Treatment of Refractive Uremic Pruritus

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Sep 24, 2015
Registry last updated: Sep 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed