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Targeting Leukotrienes in Kidney Disease

Primary Purpose

Diabetic Kidney Disease

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Montelukast
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Kidney Disease

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of ColoradoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

montelukast

Arm Description

montelukast 10mg orally once a day

Outcomes

Primary Outcome Measures

Change in Albuminuria at 3 months
Change in 24-hour urine albumin excretion at 3 months

Secondary Outcome Measures

Full Information

First Posted
April 21, 2022
Last Updated
August 15, 2022
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT05362474
Brief Title
Targeting Leukotrienes in Kidney Disease
Official Title
Targeting Leukotrienes in Kidney Disease: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
montelukast
Arm Type
Experimental
Arm Description
montelukast 10mg orally once a day
Intervention Type
Drug
Intervention Name(s)
Montelukast
Intervention Description
10mg orally once a day
Primary Outcome Measure Information:
Title
Change in Albuminuria at 3 months
Description
Change in 24-hour urine albumin excretion at 3 months
Time Frame
Baseline, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Kendrick
Phone
(303)724-4837
Email
jessica.kendrick@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Kendrick
Organizational Affiliation
University of Colorado Denver | Anschutz
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Kendrick
Email
Jessica.Kendrick@cuanschutz.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Targeting Leukotrienes in Kidney Disease

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