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NCT05362474 · ClinicalTrials.gov registry record · Phase 3

Targeting Leukotrienes in Kidney Disease

A Phase 3 study, sponsored by University of Colorado, Denver.

Terminated
Registry status
Phase 3
Development phase
6
Enrollment target

NCT05362474: Clinical Trial Phase 3 study, sponsored by University of Colorado, Denver.

NCT05362474 is a Phase 3 study that was terminated before completion, run by University of Colorado, Denver. The registered enrollment target is 6 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05362474, a Phase 3 study, was terminated before completion, sponsored by University of Colorado, Denver.

TERMINATED
Registry status
Phase 3
Development phase
6 participants
Enrollment target

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.

Primary Outcome

Change in 24-hour urine albumin excretion at 3 months

Interventions

  • DRUG Montelukast

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2022-07-01
Est. Completion 2023-06-20
Phase Phase 3
University of Colorado, Denver

1,283 total trials

Why NCT05362474 stopped before completion

NCT05362474 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Montelukast is the first listed.

NCT05362474 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05362474 about?

NCT05362474 is a clinical study titled "Targeting Leukotrienes in Kidney Disease". 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...

What is the current status of trial NCT05362474?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 6 participants. The study started on 2022-07-01. Estimated completion is 2023-06-20.

What interventions are being tested in trial NCT05362474?

The interventions under investigation include: Montelukast (DRUG).

Who is sponsoring clinical trial NCT05362474?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05362474's enrollment target sits among peer trials

6 1995th of 2000 higher than 4 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05362474, the US trial registry maintained by the National Library of Medicine. NCT05362474 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.