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Could an allergy drug protect kidneys in type 1 diabetes?

NCT ID NCT05498116

Disease control Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study tests whether montelukast, a common allergy medication, can lower protein levels in urine and improve kidney and blood vessel function in people with type 1 diabetes who have early signs of kidney disease. Inflammation is thought to play a role in diabetic kidney damage, and montelukast blocks certain inflammatory chemicals. The trial involves 50 adults taking either montelukast or a placebo daily for 6 months to measure changes in kidney and heart health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
montelukast
What this could lead to
If it works, montelukast could offer a new way to slow kidney disease progression in people with type 1 diabetes, potentially delaying dialysis or kidney failure.
What could go wrong
This is a small, early-phase trial with only 50 participants, so results may not apply broadly. Montelukast is generally safe but may not reduce urine protein enough to make a real difference.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18-80 years * Type 1 diabetes for at least 5 years * Urine albumin to creatinine ratio 30-5000 mg/g on first morning void * eGFR 30-89 ml/min/1.73m2 at time of screening * Blood pressure \<140/90 mm Hg prior to randomization * Use of angiotensin converting enzyme inhibitor or angiotensin receptor blocker with stable dose for 4 weeks * BMI \< 40 kg/m2 (FMDBA measurements can be inaccurate in severely obese patients). * Stable anti-hypertensive regimen for at least one month prior to randomization * Stable regimen of insulin delivery, i.e. automated insulin delivery (AID) system or multiple daily injections) 4 weeks prior to randomization * 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 * Anticipated initiation of dialysis or kidney transplantation within 6 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) * Penicillin allergy * Iodine allergy * Shellfish allergy * Current use of phenobarbital, rifampin or carbamazepine

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Conditions

The condition(s) this trial relates to.

Albuminuria diabetic kidney disease proteinuria type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Albuminuria

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Colorado Anschutz Medical Campus

    RECRUITING

    Aurora, Colorado, 80045, United States

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