Trial Outcomes & Findings for Targeting Leukotrienes in Kidney Disease (NCT NCT05362474)

Last Updated: 2025-05-30

Results Overview

Change in 24-hour urine albumin excretion at 3 months

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

6 participants

Primary outcome timeframe

Baseline, 3 months

Results posted on

2025-05-30

Participant milestones
Measure	Montelukast montelukast 10mg orally once a day Montelukast: 10mg orally once a day
Overall Study STARTED	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Withdrawal data not reported

Targeting Leukotrienes in Kidney Disease

Baseline characteristics by cohort
Measure	Montelukast n=6 Participants montelukast 10mg orally once a day Montelukast: 10mg orally once a day
Age, Continuous	62.3 years STANDARD_DEVIATION 6.35 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6 Participants n=5 Participants

Timeframe: Baseline, 3 months

Change in 24-hour urine albumin excretion at 3 months

Outcome measures
Measure	Montelukast n=5 Participants montelukast 10mg orally once a day Montelukast: 10mg orally once a day
Change in Albuminuria at 3 Months Baseline	1.84 mg/day Standard Deviation 1.96
Change in Albuminuria at 3 Months 3 months	1.05 mg/day Standard Deviation 0.44

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Montelukast n=5 participants at risk montelukast 10mg orally once a day Montelukast: 10mg orally once a day
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	60.0% 3/5 • Number of events 3 • 3 months

University of Colorado Denver

Phone: 303-724-4837