Montelukast for Treatment of Uremic Pruritus

NCT02559388 | Completed DMC

• 1 other identifier: IR.SUMS.REC.1394.32
• Study Type: interventional
• Target: 73
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Renal Insufficiency, Chronic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Highly sensitive CRP (hs-CRP)

  Change from Baseline in serum value at 1months

Study Arms (2)

montelukast

ACTIVE COMPARATOR

montelukast 10 milligram, daily for 30 days

Drug: Montelukast

placebo

PLACEBO COMPARATOR

Placebo one tablet for 30 days

Drug: placebo

Interventions

Montelukast DRUG

montelukast

placebo DRUG

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

placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Related Publications (1)

• Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.

  PMID: 33283264 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

montelukast

Condition Hierarchy (Ancestors)

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

Study Officials

• Mohammad Mehdi Sagheb, Professor

  Shiraz University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellowship of Nephrology

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: September 24, 2015
• Study Start: April 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 24, 2015

Record last verified: 2015-09