End-Stage Renal DiseasePhase 1NCT00490737
Safety Study to Evaluate Daptomycin in Non-infected Adults Who Are Either on Hemodialysis or Continuous Ambulatory Peritoneal Dialysis (MK-3009-021)
A Phase 1 study testing daptomycin in people with End-Stage Renal Disease, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
Trial summary
This study is to examine the safety of daptomycin in patients with End Stage Renal Disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Renal Disease
- 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
- 12 participants
- Where
- No sites listed yet
- Study dates
- 12 Aug 2007to 12 May 2008
- 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 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;
- Considered to be in appropriate health for study entry by the Investigator (e.g., no acute, debilitating medical problems) and appropriate candidate for completing study treatment;
- Male or female >18 years of age;
- If female of childbearing potential; willing to practice reliable birth control measures during study treatment, not lactating/pregnant, has a documented negative pregnancy test result within 24 hours prior to study medication administration, and willing to practice effective means of birth control for >28 days after study completion;
- If taking concomitant medications, subject must be on a relatively stable dose for at least two weeks prior to study medication administration;
- Functioning dialysis access (e.g. graft or fistula) for subjects undergoing HD and functioning dialysis access (e.g. peritoneal catheter) for subjects undergoing CAPD;
- ESRD on stable HD regimen of thrice weekly sessions with high-flux membranes or stable CAPD regimen.
Who cannot join
- If female, pregnant or lactating;
- Received an investigational drug (including experimental biologic agents) within 30 days of study entry;
- Evidence of active ongoing infection;
- Unable to discontinue use of HMG-CoA reductase inhibitor therapy for duration of study;
- Has received any dose(s) of daptomycin within 5 days prior to receiving the first dose of study drug;
- Known to be allergic or intolerant to daptomycin;
Show all 22Show fewer
- Body Mass Index (BMI) < 18.5 or > 40 kg/m2 [BMI = weight (kg)/height (m2)];
- WBC >12, 000 cells/mm3 or <2500 cells/ mm3;
- Baseline creatinine phosphokinase (CPK) values >3X ULN (upper limit of normal);
- Alanine aminotransferase (ALT) >5X ULN;
- Aspartate aminotransferase (AST) >5X ULN;
- Known HIV-infected subjects with CD4 count ≤200 cells/mm3;
- Hemoglobin < 9 gm/dL;
- Active illicit drug and/or alcohol abuse;
- Myocardial infarction within last 6 months;
- Hospitalized for non-vascular or peritoneal dialysis (PD) access issues within 30 days;
- Subjects with a history of muscular disease (e.g., polymyositis, muscular dystrophy);
- Subjects with a history of neurological disease (e.g., Guillain Barré, multiple sclerosis), except stroke >6 months prior to study entry;
- Intramuscular injection within 7 days of study drug administration;
- Has a moribund clinical condition (i.e., high likelihood of death during the next 3 days);
- Is considered unlikely to comply with study procedures or to return for scheduled post-treatment evaluations;
- Neutropenic subjects with absolute neutrophil count ≤500 cells/mm3 History of rhabdomyolysis.
About this study
Official title: An Evaluation of the Pharmacokinetic Profile and Safety and Tolerability of Multiple Doses of 6mg/kg Intravenous Daptomycin in Non-Infected Adult Subjects With End Stage Renal Disease on Hemodialysis or Continuous Ambulatory Peritoneal Dialysis
This study is to examine the safety of daptomycin in patients with End Stage Renal Disease.
Read the detailed description
This is an open label, non-randomized, non-comparative Phase 1 study designed to evaluate the PK profile, safety and tolerability of intravenous ( i.v.) daptomycin. Non-infected subjects with end stage renal disease undergoing hemodialysis (HD) or continuous ambulatory peritoneal dialysis (CAPD) will be enrolled in this in-patient study.
- Conditions
- End-Stage Renal Disease
- Being tested
- daptomycin
- Keywords
- ESRD, dialysis, hemodialysis, continuous ambulatory peritoneal dialysis
- 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
6mg/kg, i.v. infusion over 30 minutes; every 48 hours for a total of 3 doses
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis (HD) Participants | Experimental | Participants will receive daptomycin 6 mg/kg by intravenous infusion (i.v.) at 48-hours intervals (with dialysis) for a total of 3 doses. Receives: Drug: daptomycin |
| Continuous Ambulatory Peritoneal Dialysis (CAPD) Participants | Experimental | Participants will receive daptomycin 6 mg/kg, i.v., at 48-hours intervals for a total of 3 doses. Receives: Drug: daptomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
Measured: Study Day 1, 3, 5 and 7 or 8
Secondary outcomes (1)
Safety and Tolerability
Measured: Study Days 1 through 16 or 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2007 (estimated)
- Study start12 Aug 2007
- Primary completion12 May 2008
- Study completion12 May 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00490737
- Sponsor's protocol ID
- 3009-021
- Other IDs
- DAP-REN-07-01
- Status last verified
- Jan 2018
- First submitted
- 22 Jun 2007
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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
Publications
Benziger DP, Pertel PE, Donovan J, Yankelev S, Schwab RJ, Swan SK, Cannon C. Pharmacokinetics and safety of multiple doses of daptomycin 6 mg/kg in noninfected adults undergoing hemodialysis or continuous ambulatory peritoneal dialysis. Clin Nephrol. 2011 Jan;75(1):63-9.
PubMed 21176752
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Pharmacokinetic Profile and Safety and Tolerability of Multiple Doses of 6mg/kg Intravenous Daptomycin in Non-Infected Adult Subjects With End Stage Renal Disease on Hemodialysis or Continuous Ambulatory Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT00490737
- Acronym / sponsor ID
- 3009-021
- Conditions
- End-Stage Renal Disease
- Keywords
- ESRD, dialysis, hemodialysis, continuous ambulatory peritoneal dialysis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- 12 Aug 2007 (actual)
- Primary completion
- 12 May 2008 (actual)
- Study completion
- 12 May 2008 (actual)
- First posted
- 25 Jun 2007 (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.
This study is to examine the safety of daptomycin in patients with End Stage Renal Disease.
Detailed description
This is an open label, non-randomized, non-comparative Phase 1 study designed to evaluate the PK profile, safety and tolerability of intravenous ( i.v.) daptomycin. Non-infected subjects with end stage renal disease undergoing hemodialysis (HD) or continuous ambulatory peritoneal dialysis (CAPD) will be enrolled in this in-patient study.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis (HD) Participants | Experimental | Drug: daptomycinParticipants will receive daptomycin 6 mg/kg by intravenous infusion (i.v.) at 48-hours intervals (with dialysis) for a total of 3 doses. |
| Continuous Ambulatory Peritoneal Dialysis (CAPD) Participants | Experimental | Drug: daptomycinParticipants will receive daptomycin 6 mg/kg, i.v., at 48-hours intervals for a total of 3 doses. |
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;
- Considered to be in appropriate health for study entry by the Investigator (e.g., no acute, debilitating medical problems) and appropriate candidate for completing study treatment;
- Male or female >18 years of age;
- If female of childbearing potential; willing to practice reliable birth control measures during study treatment, not lactating/pregnant, has a documented negative pregnancy test result within 24 hours prior to study medication administration, and willing to practice effective means of birth control for >28 days after study completion;
- If taking concomitant medications, subject must be on a relatively stable dose for at least two weeks prior to study medication administration;
Key exclusion criteria (22 listed)
- If female, pregnant or lactating;
- Received an investigational drug (including experimental biologic agents) within 30 days of study entry;
- Evidence of active ongoing infection;
- Unable to discontinue use of HMG-CoA reductase inhibitor therapy for duration of study;
- Has received any dose(s) of daptomycin within 5 days prior to receiving the first dose of study drug;
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: Cubicin6mg/kg, i.v. infusion over 30 minutes; every 48 hours for a total of 3 doses | Drug | Continuous Ambulatory Peritoneal Dialysis (CAPD) Participants, Hemodialysis (HD) Participants |
Primary outcome
Pharmacokinetics
Time frame: Study Day 1, 3, 5 and 7 or 8
1 secondary outcome
Safety and Tolerability
Time frame: Study Days 1 through 16 or 17
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 9 Jan 2018.
- Derived from this study: PubMed 21176752Benziger DP, Pertel PE, Donovan J, Yankelev S, Schwab RJ, Swan SK, Cannon C. Pharmacokinetics and safety of multiple doses of daptomycin 6 mg/kg in noninfected adults undergoing hemodialysis or continuous ambulatory peritoneal dialysis. Clin Nephrol. 2011 Jan;75(1):63-9.
- 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
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
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
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
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing daptomycin in people with End-Stage Renal Disease, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
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 22 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 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Pharmacokinetics (time frame: Study Day 1, 3, 5 and 7 or 8). 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 NCT00490737, 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 9 Jan 2018.