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Leukotriene Antagonist

Montelukast for Diabetic Kidney Disease

Phase 3
Waitlist Available
Led By Jessica Kendrick
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Use of angiotensin converting enzyme inhibitor or angiotensin receptor blocker with stable dose for 4 weeks
History of diabetes type 1 or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months
Awards & highlights

Study Summary

This trial will investigate whether montelukast, a leukotriene antagonist, can help improve symptoms in patients with diabetic kidney disease by reducing proteinuria and improving vascular function and arterial stiffness.

Who is the study for?
This trial is for adults with stage 3 chronic kidney disease (CKD) due to diabetes, who have a certain level of protein in their urine and controlled blood pressure. They should be on stable medication regimens for hypertension and diabetes, not overly active, able to consent, have a BMI under 40, and be taking specific blood pressure meds. Excluded are those with uncontrolled high blood pressure, poor medication adherence history, severe liver issues or major psychiatric disorders.Check my eligibility
What is being tested?
The study tests if montelukast can reduce protein leakage in the urine and improve blood vessel function in diabetic kidney disease patients. Montelukast blocks leukotrienes which may help control inflammation associated with DKD.See study design
What are the potential side effects?
Montelukast might cause side effects like respiratory infections, fever, headaches or sometimes more serious ones such as mental health changes. People using corticosteroids or long-acting beta agonists aren't included because of an increased risk of neuropsychiatric reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on a stable dose of ACE inhibitor or ARB for 4 weeks.
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I have a history of diabetes, either type 1 or 2.
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My kidney function is moderately reduced.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Albuminuria at 3 months

Side effects data

From 2005 Phase 4 trial • 99 Patients • NCT00189462
16%
Cold/Upper Respiratory Infection
10%
Diarrhea
6%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Montelukast
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: montelukastExperimental Treatment1 Intervention
montelukast 10mg orally once a day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Montelukast
FDA approved

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,732 Previous Clinical Trials
2,143,578 Total Patients Enrolled
Jessica KendrickPrincipal InvestigatorUniversity of Colorado Denver | Anschutz

Media Library

Montelukast (Leukotriene Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05362474 — Phase 3
Diabetic Kidney Disease Research Study Groups: montelukast
Diabetic Kidney Disease Clinical Trial 2023: Montelukast Highlights & Side Effects. Trial Name: NCT05362474 — Phase 3
Montelukast (Leukotriene Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05362474 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can people below the age of 40 years old take part in this research?

"According to the inclusion criteria, this trial is for patients aged 30-70. However, there are 42 other clinical trials available for patients who are under 18 and 456 for patients who are over 65."

Answered by AI

Who meets the standard to be included as a test subject in this experiment?

"This study, which is investigating diabetic nephropathy, requires 20 participants that are aged between 30 and 70. Most importantly, these individuals must meet the following requirements: CKD stage 3, blood pressure <140/90 mmHg, BMI <40 kg/m2, Stable diabetes regimen for at least one month prior to enrollment, Sedentary or recreationally active (<2 days of vigorous aerobic exercise as vigorous exercise may affect vascular function measurements), urine albumin to creatinine ratio 200-5000 mg/g, use of angiotensin converting enzyme inhibitor or angiotensin receptor blocker with stable dose for 4"

Answered by AI

What is the total number of patients taking part in this clinical trial?

"That is correct. The listing on clinicaltrials.gov does show that the trial is currently looking for 20 participants at a single location. The listing was first created on July 1st, 2022 and was last updated on August 15th, 2022."

Answered by AI

Are investigators currently looking for people to participate in this clinical trial?

"Yes, according to the clinicaltrials.gov listing, this study is open for recruitment. The trial was posted on July 1st, 2022 and was updated on August 15th, 2022. They are looking for 20 participants across 1 site."

Answered by AI

What are the potential dangers of taking Montelukast?

"There is pre-existing clinical evidence to support Montelukast's safety, thus it was given a score of 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Targeting Leukotrienes in Kidney Disease
2022. "Targeting Leukotrienes in Kidney Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05362474.
~2 spots leftby Apr 2025
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