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Clinical Trial Details

Trial ID: L0982
Source ID: NCT02221583
Associated Drug: Astagraf Xl
Title: Pharmacokinetics of Immunosuppressants in Renal Transplant Candidates Who Have Undergone Laparoscopic Sleeve Gastrectomy
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: End Stage Renal Disease
Interventions: DRUG: Astagraf XL|DRUG: Prograf|DRUG: Mycophenolate mofetil
Outcome Measures: Primary: Area Under Curve (AUC), AUC of tacrolimus, MMF and their metabolites will be measured at 18 timepoints within 24 hour period on Study Day 1 and Day 8, Prior to dosing (CO), and at 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 12.5, 13, 14, 15, 16, 18, 20 and 24 hours post dosing|Maximum concentration (Cmax), Cmax of tacrolimus, MMF and their metabolites will be measured at 18 timepoints within 24 hour period on Study Day 1 and Day 8, Prior to dosing (CO), and at 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 12.5, 13, 14, 15, 16, 18, 20 and 24 hours post dosing|Time to maximum concentration (Tmax), Tmax of tacrolimus, MMF and their metabolites will be measured at 18 timepoints within 24 hour period on Study Day 1 and Day 8, Prior to dosing (CO), and at 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 12.5, 13, 14, 15, 16, 18, 20 and 24 hours post dosing|Half life (T 1/2), Half-life of tacrolimus, MMF and their metabolites will be measured at 18 timepoints within 24 hour period on Study Day 1 and Day 8, 24 hours | Secondary: Adverse events (serious and non-serious), All serious adverse events and non-serious adverse events as reported by the subject will be recorded, Study Day 1 and Day 8
Sponsor/Collaborators: Sponsor: University of Cincinnati | Collaborators: Astellas Pharma Inc
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 26
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose:
Start Date: 2014-05
Completion Date: 2015-02
Results First Posted:
Last Update Posted: 2015-05-12
Locations: University of Cincinnati, Cincinnati, Ohio, 45267, United States
URL: https://clinicaltrials.gov/show/NCT02221583