Targeting Leukotrienes in Kidney Disease

NCT05362474 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: 22-0187
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Albuminuria at 3 Months

  Change in 24-hour urine albumin excretion at 3 months

  Baseline, 3 months

Study Arms (1)

montelukast

EXPERIMENTAL

montelukast 10mg orally once a day

Drug: Montelukast

Interventions

Montelukast DRUG

10mg orally once a day

montelukast

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify 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 (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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

montelukast

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Results Point of Contact

• Title: Jessica Kendrick
• Organization: University of Colorado Denver

jessica.kendrick@cuanschutz.edu

303-724-4837

Study Officials

• Jessica Kendrick

  University of Colorado Denver | Anschutz

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: May 5, 2022
• Study Start: July 1, 2022
• Primary Completion: June 20, 2023
• Study Completion: June 20, 2023
• Last Updated: May 30, 2025
• Results First Posted: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)