Renal Insufficiency, ChronicNCT02559388
Montelukast for Treatment of Uremic Pruritus
A study testing Montelukast in people with Renal Insufficiency, Chronic, run by Shiraz University of Medical Sciences.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Insufficiency, Chronic
- What is being tested?
- Montelukast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Assessment of Montelukast Efficacy in the Treatment of Refractive 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.
Read the detailed description
Montelukast is an antileukotrien receptor antagonist that seems to be effective as an antipruritic medication via blocking inflammatory pathways.
- Conditions
- Renal Insufficiency, Chronic
- Being tested
- Montelukast, placebo
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
placeboDrug
Placebo (For Montelukast) Placebo pills manufactured for mimic 10 milligram montelukast pills
| Study group | Role | What they receive |
|---|---|---|
| montelukast | Active comparator | montelukast 10 milligram, daily for 30 days Receives: Drug: Montelukast |
| placebo | Placebo comparator | Placebo one tablet for 30 days Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Detailed score proposed by Duo for pruritus
Change from Baseline in Detailed score at 1months
Measured: Change from Baseline in Detailed score at 1months
Secondary outcomes (1)
Highly sensitive CRP (hs-CRP)
This test is a serologic biochemical test
Measured: Change from Baseline in serum value at 1months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startApr 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehdi Mahmudpour, Shiraz University of Medical Sciences
- Investigators
- Mohammad Mehdi Sagheb, Professor, Principal investigator, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559388
- Sponsor's protocol ID
- IR.SUMS.REC.1394.32
- Status last verified
- Sep 2015
- First submitted
- 9 Sep 2015
- Last updated
- 24 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33283264
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Montelukast Efficacy in the Treatment of Refractive Uremic Pruritus
- ClinicalTrials.gov ID
- NCT02559388
- Acronym / sponsor ID
- IR.SUMS.REC.1394.32
- Conditions
- Renal Insufficiency, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 24 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Montelukast is an antileukotrien receptor antagonist that seems to be effective as an antipruritic medication via blocking inflammatory pathways.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| montelukast | Active comparator | Drug: Montelukastmontelukast 10 milligram, daily for 30 days |
| placebo | Placebo comparator | Drug: placeboPlacebo one tablet for 30 days |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Montelukast | Drug | montelukast |
| placeboPlacebo (For Montelukast) Placebo pills manufactured for mimic 10 milligram montelukast pills | Drug | placebo |
Primary outcome
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
1 secondary outcome
Highly sensitive CRP (hs-CRP)
Time frame: Change from Baseline in serum value at 1months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2015.
- Derived from this study: PubMed 33283264Hercz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Mehdi Sagheb, Professor principal investigator
Shiraz University of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Montelukast in people with Renal Insufficiency, Chronic, run by Shiraz University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Detailed score proposed by Duo for pruritus (time frame: Change from Baseline in Detailed score at 1months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02559388, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2015.