Montelukast for Treatment of Uremic Pruritus

Renal Insufficiency, Chronic Clinical Trial

Official title:

Assessment of Montelukast Efficacy in the Treatment of Refractive Uremic Pruritus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02559388
• Other study ID #: IR.SUMS.REC.1394.32
• Status: Completed
• Phase: N/A
• First received: September 9, 2015
• Last updated: September 23, 2015
• Start date: April 2015
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pruritus
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Montelukast

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Highly sensitive CRP (hs-CRP)	This test is a serologic biochemical test	Change from Baseline in serum value at 1months