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New treatment option for Albuminuria
Official title Effect of Montelukast on Kidney and Vascular Function in Type 1 Diabetes
ClinicalTrials.gov ID: NCT05498116
What this study is testing
What is Montelukast?
Montelukast is an investigational medicine, given as an once-daily, being studied as a potential treatment for albuminuria.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.