Status:
TERMINATED
Targeting Leukotrienes in Kidney Disease
Lead Sponsor:
University of Colorado, Denver
Conditions:
Diabetic Kidney Disease
Eligibility:
All Genders
30-70 years
Phase:
PHASE3
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. Inf...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05362474
Start Date
July 1 2022
End Date
June 20 2023
Last Update
May 30 2025
Active Locations (1)
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1
University of Colorado
Aurora, Colorado, United States, 80045