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| Name | Class |
|---|---|
| Theravance Biopharma | INDUSTRY |
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Chronic Kidney Disease Stage 5 (CKD5) patients receiving maintenance hemodialysis are at an increased risk for developing bloodstream infections. Vancomycin is traditionally used as first-line therapy for treating these infections, but the emergence of less-susceptible bacterial strains necessitates the consideration of alternative antibiotic therapy. Telavancin is a new antibiotic that has broad-spectrum antimicrobial activity against gram-positive bacteria, including vancomycin-intermediate staphylococcus aureus. While dosing recommendations for telavancin are available for patients with normal kidney function, there are no published recommendations for CKD5 patients receiving hemodialysis. A pharmacokinetic study is needed to characterize the pharmacokinetic parameters of telavancin in these patients to determine the extent of drug removal by hemodialysis and to establish dosing recommendations for CKD5 patients on maintenance hemodialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telavancin Before Hemodialysis | Other | Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin before their normally scheduled hemodialysis session. |
|
| Telavancin After Hemodialysis | Other | Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin immediately after their normally scheduled hemodialysis session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telavancin | Drug | A single 5 mg/kg dose of telavancin is administered intravenously (IV). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce A. Mueller, PharmD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Hospital | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34613416 | Derived | Gharibian KN, Lewis SJ, Heung M, Segal JH, Salama NN, Mueller BA. Telavancin pharmacokinetics in patients with chronic kidney disease receiving haemodialysis. J Antimicrob Chemother. 2021 Dec 24;77(1):174-180. doi: 10.1093/jac/dkab370. |
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All 8 participants followed a crossover study design and completed study arm 1 (telavancin before hemodialysis) followed by a 14-day minimum wash out then study arm 2 (telavancin after hemodialysis).
Recruitment commenced on 07/07/15 at the University of Michigan outpatient dialysis clinics. The final participant enrolled in the study on 02/09/16.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Period 1: Telavancin Before Hemodialysis Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin (5 mg/kg) administered intravenously (IV) before their normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations. Period 2: Telavancin After Hemodialysis After a minimum 14-day period, participants from Period 1 receive another dose of telavancin (5 mg/kg). This dose is administered intravenously (IV) after the participant's normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Telavancin Before Hemodialysis |
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| Telavancin After Hemodialysis |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Period 1: Telavancin Before Hemodialysis Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin (5 mg/kg) administered intravenously (IV) before their normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations. Period 2: Telavancin After Hemodialysis After a minimum 14-day period, participants from Period 1 receive another dose of telavancin (5 mg/kg). This dose is administered intravenously (IV) after the participant's normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cmax of Telavancin | Peak concentration of telavancin | Posted | Mean | Standard Deviation | mcg/mL | At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Telavancin Before Hemodialysis | Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin before their normally scheduled hemodialysis session. Telavancin: A single 5 mg/kg dose of telavancin is administered intravenously (IV). Pharmacokinetic Blood Sampling: Blood samples are collected to assess telavancin plasma concentrations. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| New onset atrial flutter | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bruce A. Mueller | University of Michigan | 734-763-6629 | muellerb@med.umich.edu |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C487637 | telavancin |
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|
| Pharmacokinetic Blood Sampling | Procedure | Blood samples are collected to assess telavancin plasma concentrations. |
|
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| At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Primary | Vss of Telavancin | Volume of distribution of telavancin at steady state | Posted | Mean | Standard Deviation | mL/kg | At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48 |
|
|
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| Primary | CLobs of Telavancin | Observed clearance of telavancin | Posted | Mean | Standard Deviation | mL/h/kg | At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48 |
|
|
|
| Primary | t1/2 of Telavancin | Half-life of telavancin | Posted | Mean | Standard Deviation | hours | 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 | Posted | Mean | Standard Deviation | mcg*h/mL | At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48 |
|
|
|
| Secondary | AUC24-48 of Telavancin | Area under the telavancin concentration-time curve 24-48 hours from start of infusion | Posted | Mean | Standard Deviation | mcg*h/mL | At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48 |
|
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|
| 0 |
| 8 |
| 1 |
| 8 |
| 0 |
| 8 |
| EG001 | Telavancin After Hemodialysis | Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin immediately after their normally scheduled hemodialysis session. Telavancin: A single 5 mg/kg dose of telavancin is administered intravenously (IV). Pharmacokinetic Blood Sampling: Blood samples are collected to assess telavancin plasma concentrations. | 0 | 8 | 1 | 8 | 0 | 8 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |