NCT05362474TerminatedPhase 3
Targeting Leukotrienes in Kidney Disease: A Pilot Study
University of Colorado, Denver1 site in 1 country6 target enrollmentStarted: July 1, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Change in Albuminuria at 3 Months
Study Overview
Brief Summary
Diabetic kidney disease (DKD) is associated with significant morbidity and mortality. Identifying new treatments for DKD to be used alone or in combination with other therapies is a high priority. Inflammation plays a key role in DKD and targeting pro-inflammatory lipid mediators called leukotrienes may represent a promising therapy for DKD. The current proposal will investigate whether montelukast, a leukotriene antagonist, reduces proteinuria and improves vascular function and arterial stiffness in patients with DKD.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •CKD stage 3
- •urine albumin to creatinine ratio 200-5000 mg/g
- •blood pressure <140/90 mmHg
- •use of angiotensin converting enzyme inhibitor or angiotensin receptor blocker with stable dose for 4 weeks
- •history of diabetes type 1 or 2
- •BMI <40 kg/m2
- •Stable antihypertensive regimen for at least one month prior to enrollment
- •Stable diabetes regimen for at least one month prior to enrollment
- •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 (e.g. history of medication noncompliance, noncompliance with follow up visits, significant cognitive impairment, etc.)
- •Anticipated initiation of dialysis or kidney transplantation within 3 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)
- •Current use of SGLT2 inhibitor
- •Current use of phenobarbital, rifampin or carbamazepine.
Arms & Interventions
montelukast
Experimental
montelukast 10mg orally once a day
Intervention: Montelukast (Drug)
Outcomes
Primary Outcomes
Change in Albuminuria at 3 Months
Time Frame: Baseline, 3 months
Change in 24-hour urine albumin excretion at 3 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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