Targeting Leukotrienes in Kidney Disease

University of Colorado Denver (CU Denver)

Status and phase

Terminated

Phase 3

Conditions

Diabetic Kidney Disease

Treatments

Drug: Montelukast

Study type

Interventional

Funder types

Other

Identifiers

NCT05362474

22-0187

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

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.