Targeting Leukotrienes in Kidney Disease

NCT ID: NCT05362474

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-06-20

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.

Conditions

Diabetic Kidney Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

montelukast

montelukast 10mg orally once a day

Group Type: EXPERIMENTAL

Montelukast

Intervention Type: DRUG

10mg orally once a day

Interventions

Montelukast

10mg orally once a day

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Kendrick

Role: PRINCIPAL_INVESTIGATOR

University of Colorado Denver | Anschutz

Locations

University of Colorado

Aurora, Colorado, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

22-0187

Identifier Type: -

Identifier Source: org_study_id