AlbuminuriaPhase 4NCT05498116
Effect of Montelukast on Kidney and Vascular Function in Type 1 Diabetes
A Phase 4 study testing Montelukast in people with Albuminuria, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Albuminuria
- What is being tested?
- Montelukast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2023to Apr 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Jessica Kendrick, MD, 303-724-4837, jessica.kendrick@cuanschutz.edu
About this study
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.
- Conditions
- Albuminuria
- Being tested
- Montelukast, Placebo
- Medical subject headings
- Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
10mg daily
PlaceboOther
1 capsule daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | One capsule daily Receives: Other: Placebo |
| Montelukast | Experimental | One 10mg capsule daily Receives: Drug: Montelukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Albuminuria
Change in albuminuria from baseline to 6 months
Measured: Baseline, 6 months
Secondary outcomes (2)
Change in Brachial artery flow mediated dilation (FMD)
Change in FMD from baseline to 6 months
Measured: Baseline, 6 months
Change in Large Elastic Artery Stiffness
Change in aortic pulse wave velocity from baseline to 6 months
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start26 Jan 2023
- Primary completionFeb 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlbuminuriaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Kendrick, MD, Principal investigator, University of Colorado Denver | Anschutz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498116
- Sponsor's protocol ID
- 22-1027
- Status last verified
- Jun 2026
- First submitted
- 9 Aug 2022
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Montelukast on Kidney and Vascular Function in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05498116
- Acronym / sponsor ID
- 22-1027
- Conditions
- Albuminuria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 26 Jan 2023 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboOne capsule daily |
| Montelukast | Experimental | Drug: MontelukastOne 10mg capsule daily |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Montelukast10mg daily | Drug | Montelukast |
| Placebo1 capsule daily | Other | Placebo |
Primary outcome
Change in Albuminuria
Time frame: Baseline, 6 months
Change in albuminuria from baseline to 6 months
2 secondary outcomes
Change in Brachial artery flow mediated dilation (FMD)
Time frame: Baseline, 6 months
Change in Large Elastic Artery Stiffness
Time frame: Baseline, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Albuminuria
Active, not recruitingObservational study
Family Investigation of Nephropathy and Diabetes (F.I.N.D.)
Diabetic Nephropathy, Diabetes Mellitus
RecruitingObservational study
Hypertension in Children and Young People at Risk of Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney Disease (ADPKD
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Not yet recruitingObservational study
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)
Enrolling by invitation
RAndomized EHR-based Prescribing to Improve Disease-modifying Therapies for Cardio-Kidney-Metabolic Care (RAPID-CKM)
Chronic Kidney Disease, Type 2 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica Kendrick, MD principal investigator
University of Colorado Denver | Anschutz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Montelukast in people with Albuminuria, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Kendrick (3037244837, Jessica.Kendrick@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Albuminuria (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.