Diabetic Kidney DiseasePhase 3NCT05362474
Targeting Leukotrienes in Kidney Disease
A Phase 3 study testing Montelukast in people with Diabetic Kidney Disease, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetic Kidney Disease
- What is being tested?
- Montelukast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 20 Jun 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
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 (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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Targeting Leukotrienes in Kidney Disease: A Pilot Study
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.
- Conditions
- Diabetic Kidney Disease
- Being tested
- Montelukast
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
10mg orally once a day
| Study group | Role | What they receive |
|---|---|---|
| montelukast | Experimental | montelukast 10mg orally once a day Receives: Drug: Montelukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Albuminuria at 3 Months
Change in 24-hour urine albumin excretion at 3 months
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start1 Jul 2022
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Why it stopped: Funding not available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Kidney DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Kendrick, Principal investigator, University of Colorado Denver | Anschutz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362474
- Sponsor's protocol ID
- 22-0187
- Status last verified
- May 2025
- First submitted
- 21 Apr 2022
- Last updated
- 30 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Leukotrienes in Kidney Disease: A Pilot Study
- ClinicalTrials.gov ID
- NCT05362474
- Acronym / sponsor ID
- 22-0187
- Conditions
- Diabetic Kidney Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding not available
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 5 May 2022 (actual)
- Results
- Posted 30 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| montelukast | Experimental | Drug: Montelukastmontelukast 10mg orally once a day |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 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 (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
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 orally once a day | Drug | montelukast |
Primary outcome
Change in Albuminuria at 3 Months
Time frame: Baseline, 3 months
Change in 24-hour urine albumin excretion at 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Diabetic Nephropathies MeSH:D003928, Diabetes Mellitus, Type 2
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. This study is not recruiting at the moment.
Jessica Kendrick 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 3 study testing Montelukast in people with Diabetic Kidney Disease, 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 10 inclusion and 12 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: stopped early, as of the sponsor's last update on 30 May 2025. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Albuminuria at 3 Months (time frame: Baseline, 3 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 May 2025.