Logo 1 Logo 2

Clinical Trial Details

Trial ID: L0138
Source ID: NCT02937350
Associated Drug: D6-25-Hydroxyvitamin D3
Title: Clearance of 25-hydroxyvitamin D in Chronic Kidney Disease
Acronym: CLEAR
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02937350/results
Conditions: Chronic Kidney Disease
Interventions: DRUG: D6-25-hydroxyvitamin D3
Outcome Measures: Primary: Metabolic Clearance of D6-25(OH)D3, Metabolic clearance is calculated as the administered dose of 25(OH)D3 divided by the area under the plasma concentration-time curve (AUC). AUC is calculated using the linear trapezoidal method. Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration., 8 weeks | Secondary: AUC of D6-25(OH)D3, AUC is calculated using the linear trapezoidal method. Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration., 8 weeks|Terminal Half-life of D6-25(OH)D3, Terminal half-life is equal to ln2/k, where k is the slope of the terminal regression line estimated using ≥3 plasma concentrations. Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration., 8 weeks|Volume of Distribution of D6-25(OH)D3, Volume of distribution in the central compartment is calculated as dose/C0, where dose is the administered dose of 25(OH)D3 and C0 is the initial (estimated) concentration of drug in plasma. Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration., 8 weeks | Other: Metabolic Formation Clearance of D6-25(OH)D3 Metabolites., Metabolic formation clearance is calculated as the daughter metabolite plasma AUC divided by the AUC of D6-25(OH)D3 (metabolite/parent AUC ratio). AUC is calculated using the linear trapezoidal method. Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration., 8 weeks|Change in the Serum Concentration of Calcium, Change in the serum concentration of calcium from baseline to 7 days after 25(OH)D3 administration, 7 days|Change in the Serum Concentration of Creatinine, Change in the serum concentration of creatinine from baseline to 7 days after 25(OH)D3 administration, Baseline, 7 days|Change in the Serum Concentration of AST, Change in the serum concentration of AST from baseline to 7 days after 25(OH)D3 administration, Baseline, 7 days|Change in the Serum Concentration of ALT, Change in the serum concentration of ALT from baseline to 7 days after 25(OH)D3 administration, Baseline, 7 days
Sponsor/Collaborators: Sponsor: University of Washington | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 88
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2017-03-01
Completion Date: 2021-01-01
Results First Posted: 2021-09-01
Last Update Posted: 2021-09-01
Locations: University of Washington, Seattle, Washington, 98195, United States
URL: https://clinicaltrials.gov/show/NCT02937350