---
title: Targeting Leukotrienes in Kidney Disease
nct_id: NCT05362474
overall_status: TERMINATED
phase: PHASE3
sponsor: University of Colorado, Denver
study_type: INTERVENTIONAL
primary_condition: Diabetic Kidney Disease
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05362474.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05362474"
ct_last_update_post_date: 2025-05-30
last_seen_at: "2026-05-12T06:05:17.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Targeting Leukotrienes in Kidney Disease

**Official Title:** Targeting Leukotrienes in Kidney Disease: A Pilot Study

**NCT ID:** [NCT05362474](https://clinicaltrials.gov/study/NCT05362474)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Funding not available
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 6
- **Lead Sponsor:** University of Colorado, Denver
- **Conditions:** Diabetic Kidney Disease
- **Start Date:** 2022-07-01
- **Completion Date:** 2023-06-20
- **CT.gov Last Update:** 2025-05-30

## 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.

## Eligibility

- **Minimum age:** 30 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **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.
```

## Arms

- **montelukast** (EXPERIMENTAL) — montelukast 10mg orally once a day

## Interventions

- **Montelukast** (DRUG) — 10mg orally once a day

## Primary Outcomes

- **Change in Albuminuria at 3 Months** _(time frame: Baseline, 3 months)_ — Change in 24-hour urine albumin excretion at 3 months

## Locations (1)

- University of Colorado, Aurora, Colorado, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of colorado|aurora|colorado|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05362474.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05362474*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*