Safety Study to Evaluate Daptomycin in Non-infected Adults Who Are Either on Hemodialysis or Continuous Ambulatory Peritoneal Dialysis (MK-3009-021)

NCT00490737 | Completed Phase 1 FDA Drug

• 2 other identifiers: 3009-021DAP-REN-07-01
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is to examine the safety of daptomycin in patients with End Stage Renal Disease.

Conditions

End-Stage Renal Disease

Keywords

ESRD; dialysis; hemodialysis; continuous ambulatory peritoneal dialysis

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics

  Study Day 1, 3, 5 and 7 or 8

Secondary Outcomes (1)

• Safety and Tolerability

  Study Days 1 through 16 or 17

Study Arms (2)

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.

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.

Drug: daptomycin

Interventions

daptomycin DRUG

6mg/kg, i.v. infusion over 30 minutes; every 48 hours for a total of 3 doses

Also known as: Cubicin

Continuous Ambulatory Peritoneal Dialysis (CAPD) Participants; Hemodialysis (HD) Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

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

Related Publications (1)

• 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.

  PMID: 21176752 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Daptomycin

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2007
• First Posted: June 25, 2007
• Study Start: August 12, 2007
• Primary Completion: May 12, 2008
• Study Completion: May 12, 2008
• Last Updated: January 9, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share