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CompletedNCT01238796Updated Jan 15, 2019

A Study to Evaluate the Effect of Renal Function on the Biological Activity of Telavancin

A Phase 1 interventional study of telavancin in Kidney Diseases and End Stage Renal Disease, sponsored by Cumberland Pharmaceuticals. Completed at 4 sites in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-15.

Sponsored by Cumberland Pharmaceuticals · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
45
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the effect of renal function on the biological activity of telavancin using blood samples obtained from subjects with normal renal function, severe renal impairment, and end stage renal disease.

02

Conditions studied

  • Kidney Diseases
  • End Stage Renal Disease

Keywords

  • telavancin
  • Pharmacokinetics
  • Severe renal disease
  • VIBATIV®
  • ASP9809
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 45 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Cumberland Pharmaceuticals is the lead sponsor of 47 studies on the registry; 1 is open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Weighs at least 45 kg and body mass index of 18 to 40 kg/m2, inclusive
  • An estimated creatinine clearance value based on Cockcroft-Gault method of:

    • >80 mL/min for subjects with normal renal function
    • \<30 mL/min for subjects with severe renal impairment
    • receiving hemodialysis three times a week for subjects with end stage renal impairment
  • If female, the subject is at least 2 years postmenopausal, surgically sterile or practicing effective birth control, and is not pregnant or lactating
  • Good venous access

Exclusion criteria

Exclusion Criteria:

  • History of any clinically significant acute illness (other than renal disease and conditions related to the renal disease in renal impairment subjects, such as stable diabetes or hypertension)
  • Has had a kidney transplant that is still functioning
  • History of unexplained syncope, cardiac arrest, unexplained cardiac arrythmia or torsade de pointes, structural heart disease, prolonged QT interval, or family history of long QT syndrome
  • Known hypersensitivity to telavancin or any of the excipients in the formulation, or a history of severe allergic or anaphylactic reactions
  • History of consuming more than 7 units of alcoholic beverages per week, or history of alcoholism or substance abuse within past 2 years
  • Known to be positive for human immunodeficiency virus antibody
  • For subjects with normal renal function, has had treatment with prescription or non-prescription drugs, including complementary and alternative medicines or over-the counter medications, with the exception of oral contraceptives, hormone replacement therapy, daily aspirin, and occasional use of acetaminophen within the past 14 days
  • For subjects with renal impairment, has not been on a stable dose of concomitant medications for at least 2 weeks prior to study start or is taking any medication that would interfere with the evaluation of televancin in this study
  • Has received an experimental agent within 30 days or ten half-lives, whichever is longer, prior to study drug administration
  • Has had any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to admission
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Normal renal function

    Subjects with normal renal function

    Drug: telavancin

  • Experimental
    Severe renal impairment

    Subjects with severe renal impairment

    Drug: telavancin

  • Experimental
    End stage renal disease

    Subjects with end stage renal disease

    Drug: telavancin

Interventions

  • Drugtelavancin

    Intravenous

    Also known as: VIBATIV®, TD-6424, ASP9809

06

What researchers measure

Primary outcomes

  1. Concentration of telavancin as estimated by antibiotic potency bioassay

    Time frame: Days 1-4

  2. Concentration of telavancin as determined by standard Liquid Chromatography Tandem Mass Spectrometer (LC/MS/MS)

    Time frame: Days 1-4

Secondary outcomes

  1. Pharmacokinetic variables through analysis of blood samples

    Time frame: Days 1-4

07

Study locations

4 sites
  • Clinical Pharmacology of Miami
    Miami, Florida 33014, United States
  • Orlando Clinical Research Center
    Orlando, Florida 32809, United States
  • DaVita Clinical Research
    Minneapolis, Minnesota 55404, United States
  • New Orleans Center for Clinical Research
    Knoxville, Tennessee 37920, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01238796
Lead sponsor
Cumberland Pharmaceuticals
Responsible party
Sponsor
First posted
Nov 11, 2010
Start date
Dec 2010
Primary completion
Feb 2011
Completion
Feb 2011
Last update
Jan 15, 2019

Study contacts

Medical Director
study director · Cumberland Pharmaceuticals, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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