Clinical Trial Details
| Trial ID: | L1017 |
| Source ID: | NCT02392208 |
| Associated Drug: | Telavancin |
| Title: | Effect of Dialysis on the Pharmacokinetics of Telavancin in Patients With Chronic Kidney Disease Stage 5 |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT02392208/results |
| Conditions: | End-Stage Renal Disease|Stage 5 Chronic Kidney Disease |
| Interventions: | DRUG: Telavancin|PROCEDURE: Pharmacokinetic Blood Sampling |
| Outcome Measures: | Primary: Cmax of Telavancin, Peak concentration of telavancin, At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48|Vss of Telavancin, Volume of distribution of telavancin at steady state, At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48|CLobs of Telavancin, Observed clearance of telavancin, At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48|t1/2 of Telavancin, Half-life of telavancin, At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48 | Secondary: AUC0-24 of Telavancin, Area under the telavancin concentration-time curve 0-24 hours from start of infusion, At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48|AUC24-48 of Telavancin, Area under the telavancin concentration-time curve 24-48 hours from start of infusion, At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48 |
| Sponsor/Collaborators: | Sponsor: University of Michigan | Collaborators: Theravance Biopharma |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 8 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER |
| Start Date: | 2015-07 |
| Completion Date: | 2016-03 |
| Results First Posted: | 2017-03-30 |
| Last Update Posted: | 2017-04-04 |
| Locations: | University of Michigan Hospital, Ann Arbor, Michigan, 48109, United States |
| URL: | https://clinicaltrials.gov/show/NCT02392208 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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