Clincosm LogoSign in Get a demo

Targeting Leukotrienes in Kidney Disease

Sponsor
University of Colorado, Denver (Other)
Overall Status
Recruiting
CT.gov ID
NCT05362474
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
20
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Targeting Leukotrienes in Kidney Disease: A Pilot Study
Actual Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: montelukast

montelukast 10mg orally once a day

Drug: Montelukast
10mg orally once a day

Outcome Measures

Primary Outcome Measures

  1. Change in Albuminuria at 3 months [Baseline, 3 months]

    Change in 24-hour urine albumin excretion at 3 months

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Colorado Aurora Colorado United States 80045

Sponsors and Collaborators

  • University of Colorado, Denver

Investigators

  • Principal Investigator: Jessica Kendrick, University of Colorado Denver | Anschutz

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT05362474
Other Study ID Numbers:
  • 22-0187
First Posted:
May 5, 2022
Last Update Posted:
Aug 16, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Montelukast

Study Results

No Results Posted as of Aug 16, 2022