Chronic Kidney DiseaseNCT01012089

Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease

A study testing Daptomycin in people with Chronic Kidney Disease and Bacterial Infection, run by University of Oklahoma 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

The purpose of this study is to: 1. Study the pharmacokinetics and safety of daptomycin in children on hemodialysis (HD) and peritoneal dialysis (PD). 2. Determine urine, HD and PD clearance of daptomycin. Read more about this study

Who is it for?: Ages 12 to 17 years
Conditions the study is for: Chronic Kidney Disease, Bacterial Infection
What is being tested?: Daptomycin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: Nov 2009to Apr 2014
Phase: Interventional
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 12 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Children who are between 12-17 years of age who are either on HD or PD and whom the Pediatric Nephrology Section of the OU Children's Physicians Clinics provide care.
In addition to children on chronic HD and PD therapy, patients newly initiated on HD and PD will also be recruited for this study.
Patients with suspected or confirmed cases of dialysis related infection from gram-positive bacteria and who are receiving standard of care antibiotics.
Patients will be eligible for enrollment if they were admitted as an inpatient to the Children's hospital or as an outpatient to the dialysis clinic

Who cannot join

Patients > 17 years of age
Patients < 12 years of age
Total amount of blood drawn as part of standard of care and for pharmacokinetic analysis exceeds 3 ml/kg over an 8 week period
Taking an HMG CoA reductase inhibitor within 7 days of daptomycin administration
Having used daptomycin in the 30 days preceding study entry
Participating in any experimental procedure in the 30 days preceding study

Show all 11Show fewer

A history of muscular disease or neurological disease
Baseline creatine phosphokinase (CPK) values equal to or greater than 1.5 times the upper limit of normal (normal range 65-370 IU/L)
Hemoglobin < 9 g/dl
Hemodynamic instability within 72 hours before study enrollment
Female subjects with a positive pregnancy test or failure to take a pregnancy test

Trial locations and contacts

1 site in 1 country.

United States1 site

The Children's Hospital at the University of Oklahoma Medical Center
Oklahoma City, Oklahoma, 73013

Other trials in United States

About this study

The purpose of this study is to:

Study the pharmacokinetics and safety of daptomycin in children on hemodialysis (HD) and peritoneal dialysis (PD).
Determine urine, HD and PD clearance of daptomycin.

Read the detailed description

Infectious and sepsis events are one of the most common complications in children with chronic kidney disease. The incidence is highest in children with an access for dialysis, especially in those with catheters. Staphylococcal species account for more than 50% of access infections (ranging from 58-77%). Failure to clear the infection results in loss of dialysis access.

Daptomycin is a new antibiotic that provides coverage against most gram positive bacteria including methicillin-resistant staphylococci, vancomycin-intermediate Staphylococcus aureus, and vancomycin-resistant enterococci. The pharmacokinetics of daptomycin in children on dialysis, a group of patients who may need the medication the most, remains unknown.

Children on HD or PD with suspected or confirmed infections due to gram-positive bacteria and who are concurrently treated with standard of care antibiotics will be considered for this study. Each patient will be given a onetime dose of Cubicin (daptomycin). After receiving daptomycin, serial blood samples along with dialysis effluent and urine (obtained from non-anuric patients) will be collected to evaluate the pharmacokinetic profile of the drug.

Conditions: Chronic Kidney Disease, Bacterial Infection
Being tested: Daptomycin
Keywords: Hemodialysis, Peritoneal dialysis, Daptomycin, Pharmacokinetics
Medical subject headings: Renal Insufficiency, Chronic, Bacterial Infections

What participants receive

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

DaptomycinDrug
Also called Cubicin
Daptomycin IV 5 mg/kg one time dose

Study groups in NCT01012089
Study group	Role	What they receive
Daptomycin	Experimental	Pediatric patients on hemodialysis or peritoneal dialysis with suspected or confirmed infection and who were receiving standard of care antibiotics were also eligible to receive a single dose of daptomycin 5mg/kg IV. Serial blood draws were obtained to assess daptomycin pharmacokinetics Receives: Drug: Daptomycin

What is being measured

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

Maximum Plasma Concentration (Cmax)
Measured: 0, 0.5, 2, 3, 4.5 6, 24, and 48 hours post dose
Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC0-24)
Measured: 0, 0.5, 2, 3, 4.5, 6, and 24 hours post dose
Area Under the Concentration Time Curve From Time Zero to 48 Hours (AUC0-48)
Measured: 0, 0.5, 2, 3, 4.5 6, 24, and 48 hours post dose
Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-∞)
Measured: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose
Volume of Distribution at Steady State (Vss)
The theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug
Measured: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose
Elimination Rate Constant (Ke)
Measured: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose
Total Drug Clearance (CLtotal)
The rate at which a drug substance is removed from the body
Measured: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose
Drug Clearance Due to Dialysis (CLdialysis)
The rate at which a drug substance is removed from the body due to dialysis therapy
Measured: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose

Timeline

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

Nov 2009Apr 2014

First posted11 Nov 2009 (estimated)
Study startNov 2009
Primary completionApr 2014
Study completionApr 2014

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.
Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
More trials run by University of OklahomaThe 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 N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01012089
Sponsor's protocol ID: 2375
Status last verified: May 2018
First submitted: 9 Nov 2009
Last updated: 6 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

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 Chronic Kidney Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease
ClinicalTrials.gov ID: NCT01012089
Acronym / sponsor ID: 2375
Conditions: Chronic Kidney Disease, Bacterial Infection
Keywords: Hemodialysis, Peritoneal dialysis, Daptomycin, Pharmacokinetics
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: University of OklahomaUniversity, hospital or other
Collaborators: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Study start: Nov 2009
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 11 Nov 2009 (estimated)
Results: Posted 6 Jun 2018

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:

Study the pharmacokinetics and safety of daptomycin in children on hemodialysis (HD) and peritoneal dialysis (PD).
Determine urine, HD and PD clearance of daptomycin.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Daptomycin	Experimental	Drug: DaptomycinPediatric patients on hemodialysis or peritoneal dialysis with suspected or confirmed infection and who were receiving standard of care antibiotics were also eligible to receive a single dose of daptomycin 5mg/kg IV. Serial blood draws were obtained to assess daptomycin pharmacokinetics

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Children who are between 12-17 years of age who are either on HD or PD and whom the Pediatric Nephrology Section of the OU Children's Physicians Clinics provide care.
In addition to children on chronic HD and PD therapy, patients newly initiated on HD and PD will also be recruited for this study.
Patients with suspected or confirmed cases of dialysis related infection from gram-positive bacteria and who are receiving standard of care antibiotics.
Patients will be eligible for enrollment if they were admitted as an inpatient to the Children's hospital or as an outpatient to the dialysis clinic

Key exclusion criteria (11 listed)

Patients > 17 years of age
Patients < 12 years of age
Total amount of blood drawn as part of standard of care and for pharmacokinetic analysis exceeds 3 ml/kg over an 8 week period
Taking an HMG CoA reductase inhibitor within 7 days of daptomycin administration
Having used daptomycin in the 30 days preceding study entry

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
DaptomycinAlso: CubicinDaptomycin IV 5 mg/kg one time dose	Drug	Daptomycin

Primary outcome

Maximum Plasma Concentration (Cmax)
Time frame: 0, 0.5, 2, 3, 4.5 6, 24, and 48 hours post dose
Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC0-24)
Time frame: 0, 0.5, 2, 3, 4.5, 6, and 24 hours post dose
Area Under the Concentration Time Curve From Time Zero to 48 Hours (AUC0-48)
Time frame: 0, 0.5, 2, 3, 4.5 6, 24, and 48 hours post dose
Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-∞)
Time frame: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose
Volume of Distribution at Steady State (Vss)
Time frame: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose
The theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug
Elimination Rate Constant (Ke)
Time frame: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose
Total Drug Clearance (CLtotal)
Time frame: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose
The rate at which a drug substance is removed from the body
Drug Clearance Due to Dialysis (CLdialysis)
Time frame: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose
The rate at which a drug substance is removed from the body due to dialysis therapy

Results and safety

Results posted to the registry on 6 Jun 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Daptomycin	6	6

Primary outcome: Maximum Plasma Concentration (Cmax)

Time frame: 0, 0.5, 2, 3, 4.5 6, 24, and 48 hours post dose. Mean (Full Range). Unit: mg/L

Measure	Daptomycin Hemodialysis n = 3	Daptomycin Peritoneal Dialysis n = 3
Value	42.4 (36.1 to 46.5)	66.5 (45.1 to 97.8)

Population analysed: The PK analysis population were pediatric dialysis patients who had either confirmed or suspected infection who received appropriate antibiotic treatment of their infection along with a single dose of daptomycin

Primary outcome: Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC0-24)

Time frame: 0, 0.5, 2, 3, 4.5, 6, and 24 hours post dose. Mean (Full Range). Unit: mg∙hr/L

Measure	Daptomycin Hemodialysis n = 3	Daptomycin Peritoneal Dialysis n = 3
Value	388 (323 to 429)	708 (525 to 944)

Primary outcome: Area Under the Concentration Time Curve From Time Zero to 48 Hours (AUC0-48)

Time frame: 0, 0.5, 2, 3, 4.5 6, 24, and 48 hours post dose. Mean (Full Range). Unit: mg∙hr/L

Measure	Daptomycin Hemodialysis n = 3	Daptomycin Peritoneal Dialysis n = 3
Value	557 (454 to 617)	1051 (804 to 1412)

Primary outcome: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-∞)

Time frame: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose. Mean (Full Range). Unit: mg∙hr/L

Measure	Daptomycin Hemodialysis n = 3	Daptomycin Peritoneal Dialysis n = 3
Value	734 (579 to 874)	1477 (1142 to 2127)

Adverse events

Time frame: Safety assessments were performed on study "Day 0", "Day 1", "Day 2". Serum CPK and standard clinical laboratory evaluations were obtained at baseline and at the end of study "Day 0". A telephone follow-up was also conducted by study personnel at Day 7, 14, 21 and 28 post study drug administration to continue follow-up of potential adverse events.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Daptomycin Peritoneal Dialysis	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Daptomycin Hemodialysis	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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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.

Teresa V Lewis, Pharm.D. principal investigator

University of Oklahoma

Martin A Turman, M.D., Ph.D. principal investigator

University of Oklahoma

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

Questions about this trial

What is this clinical trial studying?

A study testing Daptomycin in people with Chronic Kidney Disease and Bacterial Infection, run by University of Oklahoma at 1 site 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 4 inclusion and 11 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 6 Jun 2018. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jun 2018). 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?

Maximum Plasma Concentration (Cmax) (time frame: 0, 0.5, 2, 3, 4.5 6, 24, and 48 hours post dose). The study lists 8 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 NCT01012089.

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 6 Jun 2018.