Montelukast for Treatment of Uremic Pruritus

Shiraz University of Medical Sciences

Status

Completed

Conditions

Renal Insufficiency, Chronic

Treatments

Drug: placebo

Drug: Montelukast

Study type

Interventional

Funder types

Other

Identifiers

NCT02559388

IR.SUMS.REC.1394.32

Details and patient eligibility

About

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.

Full description

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

Enrollment

73 patients

Sex

All

Volunteers

No Healthy Volunteers

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