Recruiting

Montelukast

Sponsor:

University of Colorado, Denver

Code:

NCT05498116

Conditions

Albuminuria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Montelukast

Placebo

Study Details

Brief summary:

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.

Conditions

Albuminuria

Study ID

NCT05498116

Start date

Jan 26, 2023

Status verified date

Jun, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 or angiotensin receptor blocker with stable dose for 4 weeks
  • BMI < 40 kg/m2 (FMDBA measurements can be inaccurate in severely obese patients).
  • Stable anti-hypertensive regimen for at least one month prior to randomization
  • Stable regimen of insulin delivery, i.e. automated insulin delivery (AID) system or multiple daily injections) 4 weeks prior to randomization
  • Sedentary or recreationally active (≤2 days of vigorous aerobic exercise as vigorous exercise may affect vascular function measurements)
  • Able to provide consent

Exclusion Criteria:

  • 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
  • Current participation in another research study
  • Pregnancy or planning to become pregnant or currently breastfeeding
  • Allergy to aspirin
  • Severe hepatic impairment (Child-Pugh Class C)
  • History of major psychiatric disorder
  • Use of inhaled or systemic corticosteroids or long-acting beta agonists (higher risk of neuropsychiatric reaction)
  • Penicillin allergy
  • Iodine allergy
  • Shellfish allergy
  • Current use of phenobarbital, rifampin or carbamazepine

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

One capsule daily

experimental: Montelukast

One 10mg capsule daily

Interventions

Montelukast

10mg daily

Placebo

1 capsule daily

Primary outcome measure

  • Change in Albuminuria [ Time Frame: Baseline, 6 months ]

Central Contacts and Locations

Central contacts

Jessica Kendrick

3037244837Jessica.Kendrick@cuanschutz.edu

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Jessica Kendrick, MD

303-724-4837jessica.kendrick@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-06-30.