Montelukast for Diabetic Nephropathy

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
University of Colorado, Aurora, CO
Diabetic Nephropathy+2 More
Montelukast - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Diabetic Nephropathy

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Diabetic Nephropathy

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Baseline, 3 months

Baseline, 3 months
Change in Albuminuria at 3 months

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Diabetic Nephropathy

Side Effects for

Montelukast
16%Cold/Upper Respiratory Infection
10%Diarrhea
6%Vomiting
0%Rash
This histogram enumerates side effects from a completed 2005 Phase 4 trial (NCT00189462) in the Montelukast ARM group. Side effects include: Cold/Upper Respiratory Infection with 16%, Diarrhea with 10%, Vomiting with 6%, Rash with 0%.

Trial Design

1 Treatment Group

montelukast
1 of 1
Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Montelukast · No Placebo Group · Phase 3

montelukast
Drug
Experimental Group · 1 Intervention: Montelukast · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Montelukast
2008
Completed Phase 4
~15460

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 3 months
Closest Location: University of Colorado · Aurora, CO
Photo of Houston University of Colorado 1Photo of Houston University of Colorado 2Photo of Houston University of Colorado 3
2007First Recorded Clinical Trial
0 TrialsResearching Diabetic Nephropathy
333 CompletedClinical Trials

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,553 Previous Clinical Trials
1,910,308 Total Patients Enrolled
1 Trials studying Diabetic Nephropathy
45 Patients Enrolled for Diabetic Nephropathy
Jessica KendrickPrincipal InvestigatorUniversity of Colorado Denver | Anschutz

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a urine albumin to creatinine ratio of 200-5000 mg/g.
Use of ACE inhibitor or ARB with stable dose for 4 weeks.
You have a history of diabetes type 1 or 2.
You have been on an antihypertensive regimen for at least one month prior to enrollment.
You are able to give informed consent.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.