Kidney DiseasesPhase 1NCT01238796
A Study to Evaluate the Effect of Renal Function on the Biological Activity of Telavancin
A Phase 1 study testing telavancin in people with Kidney Diseases and End Stage Renal Disease, run by Cumberland Pharmaceuticals at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Diseases, End Stage Renal Disease
- What is being tested?
- telavancin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2010to Feb 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
New Orleans Center for Clinical Research
Knoxville, Tennessee, 37920
Clinical Pharmacology of Miami
Miami, Florida, 33014
DaVita Clinical Research
Minneapolis, Minnesota, 55404
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: A Phase 1 Open-Label Study to Evaluate the Effect of Renal Function on the Biological Activity of Telavancin
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.
- Conditions
- Kidney Diseases, End Stage Renal Disease
- Being tested
- telavancin
- Keywords
- telavancin, Pharmacokinetics, Severe renal disease, VIBATIV®, ASP9809
- Medical subject headings
- Kidney Diseases, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telavancinDrug
Also called VIBATIV®, TD-6424, ASP9809
Intravenous
| Study group | Role | What they receive |
|---|---|---|
| Normal renal function | Experimental | Subjects with normal renal function Receives: Drug: telavancin |
| Severe renal impairment | Experimental | Subjects with severe renal impairment Receives: Drug: telavancin |
| End stage renal disease | Experimental | Subjects with end stage renal disease Receives: Drug: telavancin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of telavancin as estimated by antibiotic potency bioassay
Measured: Days 1-4
Concentration of telavancin as determined by standard Liquid Chromatography Tandem Mass Spectrometer (LC/MS/MS)
Measured: Days 1-4
Secondary outcomes (1)
Pharmacokinetic variables through analysis of blood samples
Measured: Days 1-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumberland Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Cumberland Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238796
- Sponsor's protocol ID
- 9809-CL-1407
- Status last verified
- Jan 2019
- First submitted
- 9 Nov 2010
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Label Study to Evaluate the Effect of Renal Function on the Biological Activity of Telavancin
- ClinicalTrials.gov ID
- NCT01238796
- Acronym / sponsor ID
- 9809-CL-1407
- Conditions
- Kidney Diseases, End Stage Renal Disease
- Keywords
- telavancin, Pharmacokinetics, Severe renal disease, VIBATIV®, ASP9809
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 11 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal renal function | Experimental | Drug: telavancinSubjects with normal renal function |
| Severe renal impairment | Experimental | Drug: telavancinSubjects with severe renal impairment |
| End stage renal disease | Experimental | Drug: telavancinSubjects with end stage renal disease |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- 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
Key exclusion criteria (10 listed)
- 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
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: VIBATIV®, TD-6424, ASP9809Intravenous | Drug | End stage renal disease, Normal renal function, Severe renal impairment |
Primary outcome
Concentration of telavancin as estimated by antibiotic potency bioassay
Time frame: Days 1-4
Concentration of telavancin as determined by standard Liquid Chromatography Tandem Mass Spectrometer (LC/MS/MS)
Time frame: Days 1-4
1 secondary outcome
Pharmacokinetic variables through analysis of blood samples
Time frame: Days 1-4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
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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.
Medical Director study director
Cumberland Pharmaceuticals
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing telavancin in people with Kidney Diseases and End Stage Renal Disease, run by Cumberland Pharmaceuticals at 4 sites in United States.
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 10 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 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Concentration of telavancin as estimated by antibiotic potency bioassay (time frame: Days 1-4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2019.