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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 belowSelect...
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:Select...
My high blood pressure is not under control.
Select...
I am currently taking phenobarbital, rifampin, or carbamazepine.
Select...
My liver is severely damaged.
Select...
I am currently using inhaled or systemic corticosteroids or long-acting beta agonists.
Select...
I expect to start dialysis or have a kidney transplant soon.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months
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 • NCT0018946216%
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
1,810 Previous Clinical Trials
2,920,050 Total Patients Enrolled
Jessica Kendrick, MDPrincipal InvestigatorUniversity of Colorado Denver | Anschutz
5 Previous Clinical Trials
334 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious mental health condition in your past.I am between 18 and 80 years old.You have other serious health problems that make it likely for you to live less than 1 year.I have had Type 1 diabetes for 5 years or more.My liver is severely damaged.My kidney function is moderately reduced.I am currently using inhaled or systemic corticosteroids or long-acting beta agonists.The ratio of albumin to creatinine in your urine is between 30 and 5000 mg/g in your first morning urine sample.My blood pressure medication has not changed in the last month.I have been on a stable dose of ACE inhibitor or ARB for 4 weeks.I exercise vigorously no more than 2 days a week.My high blood pressure is not under control.I am currently taking phenobarbital, rifampin, or carbamazepine.I have been on a stable insulin regimen for at least 4 weeks.Anything that might make it hard for you to follow the study's treatments.Your blood pressure should be lower than 140/90 mm Hg before starting the study.Your body mass index (BMI) is less than 40.I expect to start dialysis or have a kidney transplant soon.You are allergic to penicillin.You are allergic to aspirin.You are allergic to iodine.You are allergic to shellfish.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Montelukast
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.