Study to Evaluate Daptomycin Given During Dialysis and After Dialysis

End-stage Renal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00882557
• Other study ID #: 3009-027
• Secondary ID: DAP-RENID-08-06
• Status: Completed
• Phase: Phase 1
• First received: April 15, 2009
• Last updated: January 10, 2018
• Start date: April 29, 2009
• Est. completion date: July 17, 2009

Study information

• Verified date: January 2018
• Source: Cubist Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 17, 2009
• Est. primary completion date: July 17, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;

• 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.

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Failure Chronic Requiring Hemodialysis
• Renal Insufficiency

Intervention

Drug:
• daptomycin
intradialytic: 9 mg/kg during the last 30 minutes of dialysis
• daptomycin
6 mg/kg administered after a hemodialysis session

Locations

Country	Name	City	State
United States	West Coast Clinical Trials	Cypress	California
United States	DaVita Clinical Research	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Cubist Pharmaceuticals LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maximum Plasma Concentration	Maximum plasma concentration over the entire sampling phase directly obtained from the experimental plasma concentration time data, without interpolation.	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)
Other	Time to Maximum Concentration	Sampling time at which maximum plasma concentration occurred, obtained directly from the experimental plasma concentration time data, without interpolation.	Up to 68 hours post dose
Other	Half-life	Apparent terminal half-life.	Up to 68 hours post dose
Other	Clearance of Daptomycin	Plasma clearance is dose (µg) divided by area under the concentration versus time curve from time 0 to last quantifiable concentration time.	Up to 68 hours post dose
Other	Volume of Distribution	Volume of distribution at steady state (mL) calculated as the product of clearance and mean residence time.	Up to 68 hours post dose
Primary	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	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	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.	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).