Trial Outcomes & Findings for Effect of Dialysis on the Pharmacokinetics of Telavancin in Patients With Chronic Kidney Disease Stage 5 (NCT NCT02392208)

NCT ID: NCT02392208

Last Updated: 2017-04-04

Results Overview

Peak concentration of telavancin

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 8 participants
• Primary outcome timeframe: At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48
• Results posted on: 2017-04-04

Participant Flow

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.

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).

Participant milestones

Measure	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.
Telavancin Before Hemodialysis STARTED	8
Telavancin Before Hemodialysis COMPLETED	8
Telavancin Before Hemodialysis NOT COMPLETED	0
Telavancin After Hemodialysis STARTED	8
Telavancin After Hemodialysis COMPLETED	8
Telavancin After Hemodialysis NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	All Study Participants n=8 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.
Age, Continuous	47 years STANDARD_DEVIATION 20 • n=93 Participants
Sex: Female, Male Female	4 Participants n=93 Participants
Sex: Female, Male Male	4 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	6 Participants n=93 Participants
Race (NIH/OMB) White	2 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants

PRIMARY outcome

Timeframe: At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48

Peak concentration of telavancin

Outcome measures

Measure	All Study Participants n=8 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.
Cmax of Telavancin Period 1: Telavancin Before Hemodialysis	33.1 mcg/mL Standard Deviation 6.8
Cmax of Telavancin Period 2: Telavancin After Hemodialysis	38.1 mcg/mL Standard Deviation 10.1

PRIMARY outcome

Timeframe: At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48

Volume of distribution of telavancin at steady state

Outcome measures

Measure	All Study Participants n=8 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.
Vss of Telavancin Period 1: Telavancin Before Hemodialysis	201 mL/kg Standard Deviation 48
Vss of Telavancin Period 2: Telavancin After Hemodialysis	172 mL/kg Standard Deviation 36

PRIMARY outcome

Timeframe: At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48

Observed clearance of telavancin

Outcome measures

Measure	All Study Participants n=8 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.
CLobs of Telavancin Period 1: Telavancin Before Hemodialysis	11.8 mL/h/kg Standard Deviation 4.6
CLobs of Telavancin Period 2: Telavancin After Hemodialysis	6.1 mL/h/kg Standard Deviation 1.8

PRIMARY outcome

Timeframe: At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48

Half-life of telavancin

Outcome measures

Measure	All Study Participants n=8 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.
t1/2 of Telavancin Period 1: Telavancin Before Hemodialysis	13.4 hours Standard Deviation 2.9
t1/2 of Telavancin Period 2: Telavancin After Hemodialysis	21.4 hours Standard Deviation 5.5

SECONDARY outcome

Timeframe: At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48

Area under the telavancin concentration-time curve 0-24 hours from start of infusion

Outcome measures

Measure	All Study Participants n=8 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.
AUC0-24 of Telavancin Period 1: Telavancin Before Hemodialysis	307 mcg*h/mL Standard Deviation 77.1
AUC0-24 of Telavancin Period 2: Telavancin After Hemodialysis	465 mcg*h/mL Standard Deviation 89.5

SECONDARY outcome

Timeframe: At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48

Area under the telavancin concentration-time curve 24-48 hours from start of infusion

Outcome measures

Measure	All Study Participants n=8 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.
AUC24-48 of Telavancin Period 1: Telavancin Before Hemodialysis	121 mcg*h/mL Standard Deviation 38.3
AUC24-48 of Telavancin Period 2: Telavancin After Hemodialysis	220 mcg*h/mL Standard Deviation 53.6

Adverse Events

Telavancin Before Hemodialysis

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Telavancin After Hemodialysis

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Telavancin Before Hemodialysis n=8 participants at risk 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.	Telavancin After Hemodialysis n=8 participants at risk 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.
Cardiac disorders New onset atrial flutter	12.5% 1/8 • Number of events 1	12.5% 1/8 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr. Bruce A. Mueller

University of Michigan

Phone: 734-763-6629

Email: muellerb@med.umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place