Targeting Leukotrienes in Kidney Disease

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Treatments: Montelukast

Criteria

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.