Diabetic Kidney Disease
Conditions
Brief 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. 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.
Interventions
DRUGMontelukast
10mg orally once a day
Sponsors
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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 * 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
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 (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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Albuminuria at 3 Months | Baseline, 3 months | Change in 24-hour urine albumin excretion at 3 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Montelukast montelukast 10mg orally once a day
Montelukast: 10mg orally once a day | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Montelukast |
|---|---|
| Age, Continuous | 62.3 years STANDARD_DEVIATION 6.35 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 6 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 3 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Change in Albuminuria at 3 Months
Change in 24-hour urine albumin excretion at 3 months
Time frame: Baseline, 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Montelukast | Change in Albuminuria at 3 Months | 3 months | 1.05 mg/day | Standard Deviation 0.44 |
| Montelukast | Change in Albuminuria at 3 Months | Baseline | 1.84 mg/day | Standard Deviation 1.96 |