Montelukast for Kidney Function in Type 1 Diabetes
Effect of Montelukast on Kidney and Vascular Function in Type 1 Diabetes
Recruiting
Phase 4
Interventional Study
Albuminuria
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 50 (estimated)
- Sponsor
- University of Colorado, Denver · Other
Who this trial is looking for
This trial is looking for adults with type 1 diabetes who have signs of kidney disease. Participants will take montelukast to see if it lowers protein in the urine and improves kidney and heart function.
Are You a Good Fit for This Trial?
You may be able to join if
- I am between 18 and 80 years old.
- I have type 1 diabetes for at least 5 years.
- I have a urine test showing protein levels of 30-5000 mg/g.
- My kidney function is between 30-89 ml/min.
- My blood pressure is less than 140/90 mm Hg.
- I have been on a stable dose of certain blood pressure medications for 4 weeks.
- I have a stable routine for insulin delivery for 4 weeks.
- I am not engaging in more than 2 days of vigorous exercise per week.
You may not be able to join if
- I have serious health issues that may shorten my life expectancy.
- I have uncontrolled high blood pressure.
- I might have trouble following the study's requirements.
- I am starting dialysis or kidney transplant within 6 months.
- I am currently in another research study.
- I am pregnant, planning to become pregnant, or breastfeeding.
- I have an allergy to aspirin.
- I have a history of major mental health issues.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Check Your Eligibility
About This Trial
Kidney disease is a common problem among people with type 1 diabetes and can lead to disability, dialysis, and early death. Inflammation plays a key role in the development of kidney disease in type 1 diabetes and targeting leukotrienes, inflammatory chemicals the body releases in response to allergic reactions, may represent a promising therapy to slow the progression of diabetic kidney disease. …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age 18-80 years
* Type 1 diabetes for at least 5 years
* Urine albumin to creatinine ratio 30-5000 mg/g on first morning void
* eGFR 30-89 ml/min/1.73m2 at time of screening
* Blood pressure \<140/90 mm Hg prior to randomization
* Use of angiotensin converting enzyme inhibitor…
Contacts