End-stage Renal DiseasePhase 1NCT00882557

Study to Evaluate Daptomycin Given During Dialysis and After Dialysis

A Phase 1 study testing daptomycin in people with End-stage Renal Disease and Renal Failure Chronic Requiring Hemodialysis, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 2 sites 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 determine whether daptomycin at a higher dose given during the last 30 minutes of a dialysis session is equal to a lower dose of daptomycin given after a dialysis session. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: End-stage Renal Disease, Renal Failure Chronic Requiring Hemodialysis
What is being tested?: daptomycin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 2 sitesUnited States
Study dates: 29 Apr 2009to 17 Jul 2009
Phase: Phase 1
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

Written informed consent prior to any study-related procedure not part of normal medical care;
Male or female ≥ 18 years of age;
If female of childbearing potential; willing to practice reliable birth control measures during study treatment and for at least 28 days after study completion, not lactating or pregnant, and has a documented negative pregnancy test result within 24 hours prior to study medication administration;
End-stage renal disease on stable (for at least 2 weeks) hemodialysis regimen, three times weekly using high-flux membranes;
Functioning hemodialysis access (for example, graft or fistula);
Considered to be in appropriate health for study entry by the Investigator (for example, no acute, debilitating medical problems) and appropriate candidate for completing study treatment;
If taking concomitant medications, subject must be on a relatively stable dose for at least two weeks prior to study drug administration.

Who cannot join

Received an investigational drug (including experimental biologic agents) within 30 days of study drug administration;
Has received any dose of daptomycin within 7 days prior to study drug administration;
Known to be allergic or intolerant to daptomycin;
Evidence of active ongoing infection;
Known human immunodeficiency virus (HIV) infection with CD4 count ≤ 200 cells/mm3;
Active illicit drug use or alcohol abuse;

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Myocardial infarction within last 6 months;
Subject with a history of muscular disease (for example, polymyositis, muscular dystrophy);
Subject with a history of neurological disease (for example, Guillain Barré, multiple sclerosis), except stroke > 6 months prior to study entry;
Intramuscular injection within 7 days of study drug administration;
Body mass index (BMI) ≤ 18.5 or ≥ 40 kg/m2 (BMI = weight [kg]/height [m2]);
WBC ≥ 12, 000 cells/mm3 or ≤ 2500 cells/ mm3;
Neutropenic subject with absolute neutrophil count ≤ 500 cells/mm3;
Baseline CPK values ≥ 3X ULN (upper limit of normal);
Alanine aminotransferase (ALT) > 5XULN;
Aspartate aminotransferase (AST) > 5XULN;
Hemoglobin ≤ 9 gm/dL;
Is considered unlikely to comply with study procedures or to return for scheduled post-treatment evaluations;
History of rhabdomyolysis.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

West Coast Clinical Trials
Cypress, California, 90630
DaVita Clinical Research
Minneapolis, Minnesota, 55404

Other trials in United States

About this study

Official title: A Prospective, Randomized, Crossover-design Study to Evaluate the Pharmacokinetics and Safety of Daptomycin Administered at 9 mg/kg During and 6 mg/kg After Hemodialysis

Conditions: End-stage Renal Disease, Renal Failure Chronic Requiring Hemodialysis
Being tested: daptomycin
Keywords: End-stage renal disease, hemodialysis, chronic renal failure
Medical subject headings: Kidney Failure, Chronic

What participants receive

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

daptomycinDrug
Also called Cubicin
intradialytic: 9 mg/kg during the last 30 minutes of dialysis
daptomycinDrug
Also called Cubicin
6 mg/kg administered after a hemodialysis session

Study groups in NCT00882557
Study group	Role	What they receive
A	Experimental	9 mg/kg of daptomycin administered during the last 30 minutes of a hemodialysis session. Receives: Drug: daptomycin
B	Experimental	Post dialysis dosing Receives: Drug: daptomycin

What is being measured

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

Evaluation of Area Under the Curve From Time 0 to Infinity
Area under the plasma concentration versus time curve from time 0 to infinity for daptomycin doses
Measured: Within 30 minutes prior to the start of the infusion, mid-infusion, and end of the infusion; at 1, 2, 4, 6, 9, 24, and 48 hours after the end of the infusion; and just prior to the next hemodialysis session (i.e., 68 hours post-infusion)

Secondary outcomes (1)

Treatment-emergent Adverse Events
Safety was monitored throughout the study, including observation and reports of AEs as well as changes in physical findings, vital signs, ECGs, and laboratory tests.
Measured: Up to 9 days after the last dose of study drug administration (Day 13 to Day 17 for those dosed on Day 8 and Day 20 to Day 24 for those dosed on Day 15).

Timeline

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

29 Apr 200917 Jul 2009

First posted16 Apr 2009 (estimated)
Study start29 Apr 2009
Primary completion17 Jul 2009
Study completion17 Jul 2009

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 End-stage Renal DiseaseStudies 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00882557
Sponsor's protocol ID: 3009-027
Other IDs: DAP-RENID-08-06
Status last verified: Jan 2018
First submitted: 15 Apr 2009
Last updated: 6 Feb 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

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?

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Study at a glance

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

Official title: A Prospective, Randomized, Crossover-design Study to Evaluate the Pharmacokinetics and Safety of Daptomycin Administered at 9 mg/kg During and 6 mg/kg After Hemodialysis
ClinicalTrials.gov ID: NCT00882557
Acronym / sponsor ID: 3009-027
Conditions: End-stage Renal Disease, Renal Failure Chronic Requiring Hemodialysis
Keywords: End-stage renal disease, hemodialysis, chronic renal failure
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
Study start: 29 Apr 2009 (actual)
Primary completion: 17 Jul 2009 (actual)
Study completion: 17 Jul 2009 (actual)
First posted: 16 Apr 2009 (estimated)
Results: Posted 25 Oct 2011

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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
A	Experimental	Drug: daptomycin9 mg/kg of daptomycin administered during the last 30 minutes of a hemodialysis session.
B	Experimental	Drug: daptomycinPost dialysis dosing

Who may qualify

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

Key inclusion criteria (7 listed)

Written informed consent prior to any study-related procedure not part of normal medical care;
Male or female ≥ 18 years of age;
If female of childbearing potential; willing to practice reliable birth control measures during study treatment and for at least 28 days after study completion, not lactating or pregnant, and has a documented negative pregnancy test result within 24 hours prior to study medication administration;
End-stage renal disease on stable (for at least 2 weeks) hemodialysis regimen, three times weekly using high-flux membranes;
Functioning hemodialysis access (for example, graft or fistula);

Key exclusion criteria (19 listed)

Received an investigational drug (including experimental biologic agents) within 30 days of study drug administration;
Has received any dose of daptomycin within 7 days prior to study drug administration;
Known to be allergic or intolerant to daptomycin;
Evidence of active ongoing infection;
Known human immunodeficiency virus (HIV) infection with CD4 count ≤ 200 cells/mm3;

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: Cubicinintradialytic: 9 mg/kg during the last 30 minutes of dialysis	Drug	A
daptomycinAlso: Cubicin6 mg/kg administered after a hemodialysis session	Drug	B

Primary outcome

Evaluation of Area Under the Curve From Time 0 to Infinity
Time frame: Within 30 minutes prior to the start of the infusion, mid-infusion, and end of the infusion; at 1, 2, 4, 6, 9, 24, and 48 hours after the end of the infusion; and just prior to the next hemodialysis session (i.e., 68 hours post-infusion)
Area under the plasma concentration versus time curve from time 0 to infinity for daptomycin doses

1 secondary outcome

Treatment-emergent Adverse Events
Time frame: Up to 9 days after the last dose of study drug administration (Day 13 to Day 17 for those dosed on Day 8 and Day 20 to Day 24 for those dosed on Day 15).

Results and safety

Results posted to the registry on 25 Oct 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence BA	8	6
Sequence AB	8	7

Primary outcome: Evaluation of Area Under the Curve From Time 0 to Infinity

Time frame: Within 30 minutes prior to the start of the infusion, mid-infusion, and end of the infusion; at 1, 2, 4, 6, 9, 24, and 48 hours after the end of the infusion; and just prior to the next hemodialysis session (i.e., 68 hours post-infusion). Median (Full Range). Unit: hr*ug/mL

Measure	6 mg/kg After Hemodialysis (Regimen B) n = 13	9 mg/kg During Hemodialysis (Regimen A) n = 13
Value	1692 (962 to 2524)	2708 (1719 to 4010)

Population analysed: The primary endpoints are measured on the PK population, defined as all subjects who received both the 6 mg/kg dose and 9 mg/kg dose

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 9 days after the last dose of study drug administration (Day 13 to Day 17 for those dosed on Day 8 and Day 20 to Day 24 for those dosed on Day 15).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sequence BA	0 of 8 (0%)	1 of 8 (12.5%)	Not reported
Sequence AB	0 of 7 (0%)	3 of 7 (42.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

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End-stage Renal Disease (ESRD), Kidney Transplantation
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.

Alistair Wheeler, MD, MFPM study director

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

2 sites 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 19 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 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

Yes. Results are posted in the registry (first posted 25 Oct 2011). 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?

Evaluation of Area Under the Curve From Time 0 to Infinity (time frame: Within 30 minutes prior to the start of the infusion, mid-infusion, and end of the infusion; at 1, 2, 4, 6, 9, 24, and 48 hours after the end of the infusion; and just prior to the next hemodialysis session (i.e., 68 hours post-infusion)). 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 NCT00882557.

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 Feb 2018.