Targeting Leukotrienes in Kidney Disease

Diabetic Kidney Disease Clinical Trial

Official title:

Targeting Leukotrienes in Kidney Disease: A Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05362474
• Other study ID #: 22-0187
• Status: Terminated
• Phase: Phase 3
• Start date: July 1, 2022
• Est. completion date: June 20, 2023

Study information

• Verified date: April 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: June 20, 2023
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases

Intervention

Drug:
• Montelukast
10mg orally once a day

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Albuminuria at 3 months	Change in 24-hour urine albumin excretion at 3 months	Baseline, 3 months