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. The current proposal will investigate whether montelukast, a leukotriene blocker, lowers increased levels of protein in the urine (an early marker of diabetic kidney disease), and improves kidney and cardiovascular function in people with type 1 diabetes and kidney disease.
Eligibility criteria
Qualifiers
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
Disqualifiers
Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year
Uncontrolled hypertension
Factors judged to limit adherence to interventions
Anticipated initiation of dialysis or kidney transplantation within 6 months
Trial design
Treatments tested in this trial
- Montelukast
- Placebo