End-Stage Renal DiseasePhase 4NCT02392208

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

A Phase 4 study testing Telavancin and Pharmacokinetic Blood Sampling in people with End-Stage Renal Disease and Stage 5 Chronic Kidney Disease, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: End-Stage Renal Disease, Stage 5 Chronic Kidney Disease
What is being tested?: Telavancin and Pharmacokinetic Blood Sampling
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: Jul 2015to Mar 2016
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥ 18 years of age
Within 50 - 150 % of ideal body weight and greater than 40 kg
CKD5 receiving maintenance hemodialysis for ≥ 3 months
Creatinine Clearance estimate < 10 mL/min
Not received telavancin within the past month
No concurrent illness or evidence of infection
Able to give informed consent

Who cannot join

Pre-study Hemoglobin < 9.0 g/dL
Plasma Albumin < 2.5 g/dL
Pregnancy
Breastfeeding
QTc interval > 470 msec on EKG obtained within the last 6 months
Receiving concomitant QT prolonging agents

Show all 13Show fewer

Receiving warfarin or low molecular weight heparin products
Known allergy to telavancin or vancomycin
Unstable blood pressure control
Need for routine large fluid removal during dialysis (> 4 liters)
Diagnosis of liver disease with a Child Pugh score of C or higher
Dialysis isolation requirements due to Hepatitis B
Participating concurrently in another investigational drug study

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan Hospital
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

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.

Conditions: End-Stage Renal Disease, Stage 5 Chronic Kidney Disease
Being tested: Telavancin, Pharmacokinetic Blood Sampling
Keywords: telavancin, end-stage renal disease, ESRD, pharmacokinetics, hemodialysis, chronic kidney disease, CKD, dialysis, Vibativ
Medical subject headings: Kidney Failure, Chronic, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TelavancinDrug
Also called Vibativ
A single 5 mg/kg dose of telavancin is administered intravenously (IV).
Pharmacokinetic Blood SamplingProcedure or surgery
Also called PK Sampling
Blood samples are collected to assess telavancin plasma concentrations.

Study groups in NCT02392208
Study group	Role	What they receive
Telavancin Before Hemodialysis	Other	Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin before their normally scheduled hemodialysis session. Receives: Drug: Telavancin; Procedure: Pharmacokinetic Blood Sampling
Telavancin After Hemodialysis	Other	Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin immediately after their normally scheduled hemodialysis session. Receives: Drug: Telavancin; Procedure: Pharmacokinetic Blood Sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax of Telavancin
Peak concentration of telavancin
Measured: 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
Measured: At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48
CLobs of Telavancin
Observed clearance of telavancin
Measured: At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48
t1/2 of Telavancin
Half-life of telavancin
Measured: At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48

Secondary outcomes (2)

AUC0-24 of Telavancin
Area under the telavancin concentration-time curve 0-24 hours from start of infusion
Measured: 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
Measured: At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2015Mar 2016

First posted18 Mar 2015 (estimated)
Study startJul 2015
Primary completionMar 2016
Study completionMar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for End-Stage Renal DiseaseStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02392208
Sponsor's protocol ID: HUM00095470
Status last verified: Mar 2017
First submitted: 12 Mar 2015
Last updated: 4 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 34613416

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All End-Stage Renal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Dialysis on the Pharmacokinetics of Telavancin in Patients With Chronic Kidney Disease Stage 5
ClinicalTrials.gov ID: NCT02392208
Acronym / sponsor ID: HUM00095470
Conditions: End-Stage Renal Disease, Stage 5 Chronic Kidney Disease
Keywords: telavancin, end-stage renal disease, ESRD, pharmacokinetics, hemodialysis, chronic kidney disease, CKD, dialysis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: Theravance Biopharma
Study start: Jul 2015
Primary completion: Mar 2016 (actual)
Study completion: Mar 2016 (actual)
First posted: 18 Mar 2015 (estimated)
Results: Posted 30 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Telavancin Before Hemodialysis	Other	Drug: Telavancin, Procedure: Pharmacokinetic Blood SamplingStage 5 Chronic Kidney Disease patients receive a single dose of telavancin before their normally scheduled hemodialysis session.
Telavancin After Hemodialysis	Other	Drug: Telavancin, Procedure: Pharmacokinetic Blood SamplingStage 5 Chronic Kidney Disease patients receive a single dose of telavancin immediately after their normally scheduled hemodialysis session.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

≥ 18 years of age
Within 50 - 150 % of ideal body weight and greater than 40 kg
CKD5 receiving maintenance hemodialysis for ≥ 3 months
Creatinine Clearance estimate < 10 mL/min
Not received telavancin within the past month

Key exclusion criteria (13 listed)

Pre-study Hemoglobin < 9.0 g/dL
Plasma Albumin < 2.5 g/dL
Pregnancy
Breastfeeding
QTc interval > 470 msec on EKG obtained within the last 6 months

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TelavancinAlso: VibativA single 5 mg/kg dose of telavancin is administered intravenously (IV).	Drug	Telavancin After Hemodialysis, Telavancin Before Hemodialysis
Pharmacokinetic Blood SamplingAlso: PK SamplingBlood samples are collected to assess telavancin plasma concentrations.	Procedure or surgery	Telavancin After Hemodialysis, Telavancin Before Hemodialysis

Primary outcome

Cmax of Telavancin
Time frame: At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48
Peak concentration of telavancin
Vss of Telavancin
Time frame: At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48
Volume of distribution of telavancin at steady state
CLobs of Telavancin
Time frame: At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48
Observed clearance of telavancin
t1/2 of Telavancin
Time frame: At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48
Half-life of telavancin

2 secondary outcomes

AUC0-24 of Telavancin
Time frame: At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48
AUC24-48 of Telavancin
Time frame: At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48

Results and safety

Results posted to the registry on 30 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Study Participants	8	8

Primary outcome: Cmax of Telavancin

Time frame: At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48. Mean (Standard Deviation). Unit: mcg/mL

Measure	All Study Participants n = 8
Period 1: Telavancin Before Hemodialysis	33.1 (6.8)
Period 2: Telavancin After Hemodialysis	38.1 (10.1)

Primary outcome: Vss of Telavancin

Time frame: At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48. Mean (Standard Deviation). Unit: mL/kg

Measure	All Study Participants n = 8
Period 1: Telavancin Before Hemodialysis	201 (48)
Period 2: Telavancin After Hemodialysis	172 (36)

Primary outcome: CLobs of Telavancin

Time frame: At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48. Mean (Standard Deviation). Unit: mL/h/kg

Measure	All Study Participants n = 8
Period 1: Telavancin Before Hemodialysis	11.8 (4.6)
Period 2: Telavancin After Hemodialysis	6.1 (1.8)

Primary outcome: t1/2 of Telavancin

Time frame: At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48. Mean (Standard Deviation). Unit: hours

Measure	All Study Participants n = 8
Period 1: Telavancin Before Hemodialysis	13.4 (2.9)
Period 2: Telavancin After Hemodialysis	21.4 (5.5)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Telavancin Before Hemodialysis	1 of 8 (12.5%)	0 of 8 (0%)	0 of 8
Telavancin After Hemodialysis	1 of 8 (12.5%)	0 of 8 (0%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34613416Gharibian 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.

Related trials for End-Stage Renal Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bruce A. Mueller, PharmD principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax of Telavancin (time frame: At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02392208, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017; AzTrials last refreshed its copy on 8 Nov 2026.