NCT05362474

Targeting Leukotrienes in Kidney Disease

Terminated Phase 3 Results posted Last updated 30 May 2025

What this trial tests

Phase 3 trial testing Montelukast in Diabetic Kidney Disease in 6 participants. Terminated before completion.

Timeline

1 July 2022

Primary endpoint
20 June 2023

20 June 2023

Quick facts

Lead sponsor	University of Colorado, Denver
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	1 July 2022
Primary completion	20 June 2023
Estimated completion	20 June 2023
Sites	1 location across United States

Drugs / interventions tested

• Montelukast (montelukast) — full drug profile →

Conditions studied

• Diabetic Kidney Disease — all drugs for Diabetic Kidney Disease →

Sponsor

University of Colorado, Denver

Who can join

Adults 30 to 70, any sex, with Diabetic Kidney Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Albuminuria at 3 Months Primary · Baseline, 3 months

Change in 24-hour urine albumin excretion at 3 months

Baseline

Group	Value	95% CI
Montelukast	1.84	± 1.96

3 months

Group	Value	95% CI
Montelukast	1.05	± 0.44

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Montelukast

Serious: 0/5 (0%)

Deaths: 0/5

Other adverse events (1 terms — click to expand)

Reaction	System	Montelukast
Upper respiratory infection	Respiratory, thoracic and mediastinal disorders	—

Data from ClinicalTrials.gov NCT05362474 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Cysteine Leukotriene Receptor Antagonist-Montelukast Effects on Diabetic Retinal Microvascular Endothelial Cells Curtail Autophagy.
   Awad AM, Seetharaman ATM, Hossain MS, Elshaer SL, et al · · 2024 · cited 7× · PMID 39504050 · DOI 10.1167/iovs.65.13.15