A Phase 4 interventional study of Montelukast and Placebo in Albuminuria, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by University of Colorado, Denver · Phase 4, Interventional, and Treatment
Among 50 studies in Albuminuria with a site in United States — 9 open to participants now, 11 under way, none of them phase 3. Albuminuria · United States.
Among the 50 studies in Albuminuria with a site in United States, this one is the 24th largest by planned enrollment of the 42 interventional ones, is one of 2 that started in 2023, is one of 6 in phase 4, and was the 40th registered.
142 studies on the registry are indexed under Albuminuria; 24 are open to participants now.
This study's planned enrollment of 50 is below the median of 69 across 115 interventional studies indexed under Albuminuria.
Browse Albuminuria studies →9 of the 50 studies in Albuminuria with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 12 Albuminuria studies recruiting now, 3 (25%) set no upper age limit and 5 (42%) stop at 75 or younger; 3 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →50 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 2 started in 2023.
Median enrollment 60 across the 42 interventional studies, 403 across the 8 observational. Of the 38 that completed or were terminated, 20 (53%) have results posted.
15 of 50 have an industry lead sponsor. The 10 most frequent:
University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
University of Colorado, Denver has 1 study filed under Albuminuria — fewer than ten, so there is no comparison to draw.
3 of the studies in Albuminuria with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04752293Wake Forest University Health SciencesPediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE) | 2026-12 |
| NCT05498116University of Colorado, DenverEffect of Montelukast on Kidney and Vascular Function in Type 1 Diabetes | 2027-02 |
| NCT06059664University of North Carolina, Chapel HillThe EFfect of FinErenone in Kidney TransplantiOn Recipients: The EFFEKTOR Study | 2027-03-31 |
Among the 50 studies in Albuminuria with a site in United States, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One capsule daily
Other: Placebo
One 10mg capsule daily
Drug: Montelukast
10mg daily
1 capsule daily
Change in Albuminuria
Change in albuminuria from baseline to 6 months
Time frame: Baseline, 6 months
Change in Brachial artery flow mediated dilation (FMD)
Change in FMD from baseline to 6 months
Time frame: Baseline, 6 months
Change in Large Elastic Artery Stiffness
Change in aortic pulse wave velocity from baseline to 6 months
Time frame: Baseline, 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2023 (actual). Primary completion is estimated for Feb 2027, 49 months after the start.
How these figures are worked out, and which studies are left out of them.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Montelukast
University of Colorado, Denver →