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Leukotriene Blocker

Montelukast for Kidney Disease in Type 1 Diabetes

Phase 4
Recruiting
Led By Jessica Kendrick, MD
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
Age 18-80 years
Type 1 diabetes for at least 5 years
Must not have
Uncontrolled hypertension
Current use of phenobarbital, rifampin or carbamazepine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial will explore if a drug to block inflammation can slow the progression of kidney disease in people with type 1 diabetes.

Who is the study for?
This trial is for adults aged 18-80 with type 1 diabetes for at least five years, showing early signs of kidney disease (protein in urine), and on a stable regimen of blood pressure medication and insulin. They should be sedentary or lightly active, not severely obese, and have moderately functioning kidneys. Excluded are those with other serious health issues, current study participants, uncontrolled hypertension, pregnant/breastfeeding women, certain drug users/allergies.
What is being tested?
The trial tests if Montelukast can reduce protein levels in the urine (a sign of kidney disease) and improve kidney/heart health in people with type 1 diabetes. Participants will either receive Montelukast or a placebo to compare effects.
What are the potential side effects?
Montelukast may cause side effects like respiratory infections, fever, headaches, sore throat; severe reactions include allergic responses or mood-related changes. The exact side effects within this specific diabetic population will be studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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I have had Type 1 diabetes for 5 years or more.
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My kidney function is moderately reduced.
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I have been on a stable dose of ACE inhibitor or ARB for 4 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My high blood pressure is not under control.
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I am currently taking phenobarbital, rifampin, or carbamazepine.
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My liver is severely damaged.
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I am currently using inhaled or systemic corticosteroids or long-acting beta agonists.
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I expect to start dialysis or have a kidney transplant soon.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Albuminuria
Secondary study objectives
Change in Brachial artery flow mediated dilation (FMD)
Change in Large Elastic Artery Stiffness

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

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MontelukastExperimental Treatment1 Intervention
One 10mg capsule daily
Group II: PlaceboPlacebo Group1 Intervention
One capsule daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Montelukast
2008
Completed Phase 4
~15460

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,806 Previous Clinical Trials
2,822,827 Total Patients Enrolled
Jessica Kendrick, MDPrincipal InvestigatorUniversity of Colorado Denver | Anschutz
5 Previous Clinical Trials
334 Total Patients Enrolled

Media Library

Montelukast (Leukotriene Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT05498116 — Phase 4
Type 2 Diabetes Research Study Groups: Placebo, Montelukast
Type 2 Diabetes Clinical Trial 2023: Montelukast Highlights & Side Effects. Trial Name: NCT05498116 — Phase 4
Montelukast (Leukotriene Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05498116 — Phase 4
~16 spots leftby Oct 2025
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