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NCT05498116 · ClinicalTrials.gov registry record · Phase 4
Effect of Montelukast on Kidney and Vascular Function in Type 1 Diabetes
A Phase 4 study of Albuminuria, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05498116: Recruiting Phase 4 study of Albuminuria, sponsored by University of Colorado, Denver.
NCT05498116 is a Phase 4 study of Albuminuria that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 50 participants, below the 25,268-participant average among 4 other Albuminuria trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05498116, a Phase 4 study of Albuminuria, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
Kidney disease is a common problem among people with type 1 diabetes and can lead to disability, dialysis, and early death. Inflammation plays a key role in the development of kidney disease in type 1 diabetes and targeting leukotrienes, inflammatory chemicals the body releases in response to allergic reactions, may represent a promising therapy to slow the progression of diabetic kidney disease. The current proposal will investigate whether montelukast, a leukotriene blocker, lowers increased levels of protein in the urine (an early marker of diabetic kidney disease), and improves kidney and cardiovascular function in people with type 1 diabetes and kidney disease.
Primary Outcome
Change in albuminuria from baseline to 6 months
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Montelukast
Study Locations (1)
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2023-01-26 |
| Est. Completion | 2025-10 |
| Phase | Phase 4 |
What NCT05498116 shows while recruiting
NCT05498116 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 25,268-participant average among 4 other Albuminuria trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Albuminuria appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05498116 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT05498116 about?
NCT05498116 is a clinical study titled "Effect of Montelukast on Kidney and Vascular Function in Type 1 Diabetes". Kidney disease is a common problem among people with type 1 diabetes and can lead to disability, dialysis, and early death. Inflammation plays a key role in the development of kidney disease in type 1 diabetes and targeting leukotrienes, inflammatory chemicals the body releases in response to allerg...
What is the current status of trial NCT05498116?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2023-01-26. Estimated completion is 2025-10.
What conditions does trial NCT05498116 study?
This clinical trial studies the following conditions: Albuminuria.
What interventions are being tested in trial NCT05498116?
The interventions under investigation include: Placebo (OTHER), Montelukast (DRUG).
Who is sponsoring clinical trial NCT05498116?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05498116 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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