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Effect of Dialysis on the Pharmacokinetics of Telavancin in Patients With Chronic Kidney Disease Stage 5

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ClinicalTrials.gov Identifier: NCT02392208
Recruitment Status : Completed
First Posted : March 18, 2015
Results First Posted : March 30, 2017
Last Update Posted : April 4, 2017
Sponsor:
Collaborator:
Theravance Biopharma
Information provided by (Responsible Party):
Bruce A. Mueller, University of Michigan

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions End-Stage Renal Disease
Stage 5 Chronic Kidney Disease
Interventions Drug: Telavancin
Procedure: Pharmacokinetic Blood Sampling
Enrollment 8
Recruitment Details 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.
Pre-assignment Details 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).
Arm/Group Title All Study Participants
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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.

Period Title: Telavancin Before Hemodialysis
Started 8
Completed 8
Not Completed 0
Period Title: Telavancin After Hemodialysis
Started 8
Completed 8
Not Completed 0
Arm/Group Title All Study Participants
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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.

Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
47  (20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
4
  50.0%
Male
4
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
8
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
6
  75.0%
White
2
  25.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Cmax of Telavancin
Hide Description Peak concentration of telavancin
Time Frame At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Study Participants
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: mcg/mL
Period 1: Telavancin Before Hemodialysis 33.1  (6.8)
Period 2: Telavancin After Hemodialysis 38.1  (10.1)
2.Primary Outcome
Title Vss of Telavancin
Hide Description Volume of distribution of telavancin at steady state
Time Frame At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Study Participants
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: mL/kg
Period 1: Telavancin Before Hemodialysis 201  (48)
Period 2: Telavancin After Hemodialysis 172  (36)
3.Primary Outcome
Title CLobs of Telavancin
Hide Description Observed clearance of telavancin
Time Frame At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Study Participants
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: mL/h/kg
Period 1: Telavancin Before Hemodialysis 11.8  (4.6)
Period 2: Telavancin After Hemodialysis 6.1  (1.8)
4.Primary Outcome
Title t1/2 of Telavancin
Hide Description Half-life of telavancin
Time Frame At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Study Participants
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: hours
Period 1: Telavancin Before Hemodialysis 13.4  (2.9)
Period 2: Telavancin After Hemodialysis 21.4  (5.5)
5.Secondary Outcome
Title AUC0-24 of Telavancin
Hide Description Area under the telavancin concentration-time curve 0-24 hours from start of infusion
Time Frame At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Study Participants
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: mcg*h/mL
Period 1: Telavancin Before Hemodialysis 307  (77.1)
Period 2: Telavancin After Hemodialysis 465  (89.5)
6.Secondary Outcome
Title AUC24-48 of Telavancin
Hide Description Area under the telavancin concentration-time curve 24-48 hours from start of infusion
Time Frame At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Study Participants
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: mcg*h/mL
Period 1: Telavancin Before Hemodialysis 121  (38.3)
Period 2: Telavancin After Hemodialysis 220  (53.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Telavancin Before Hemodialysis Telavancin After Hemodialysis
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Telavancin Before Hemodialysis Telavancin After Hemodialysis
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)      0/8 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Telavancin Before Hemodialysis Telavancin After Hemodialysis
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/8 (12.50%)      1/8 (12.50%)    
Cardiac disorders     
New onset atrial flutter *  1/8 (12.50%)  1 1/8 (12.50%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Telavancin Before Hemodialysis Telavancin After Hemodialysis
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/8 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Bruce A. Mueller
Organization: University of Michigan
Phone: 734-763-6629
EMail: muellerb@med.umich.edu
Layout table for additonal information
Responsible Party: Bruce A. Mueller, University of Michigan
ClinicalTrials.gov Identifier: NCT02392208     History of Changes
Other Study ID Numbers: HUM00095470
First Submitted: March 12, 2015
First Posted: March 18, 2015
Results First Submitted: January 18, 2017
Results First Posted: March 30, 2017
Last Update Posted: April 4, 2017