Study to Evaluate Daptomycin Given During Dialysis and After Dialysis

Phase 1

Completed

• Conditions: End-stage Renal Disease; Renal Failure Chronic Requiring Hemodialysis
• Interventions: Drug: daptomycin

• Registration Number: NCT00882557
• Lead Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-15
• Study First Submitted QC: 2009-04-15
• Study First Posted: 2009-04-16
• Study Start: 2009-04-29
• Primary Completion: 2009-07-17
• Study Completion: 2009-07-17
• Results First Submitted: 2011-07-19
• Results First Submitted QC: 2011-09-16
• Results First Posted: 2011-10-25
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-10
• Last Update Posted: 2018-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B	daptomycin	Post dialysis dosing
A	daptomycin	9 mg/kg of daptomycin administered during the last 30 minutes of a hemodialysis session.

Primary Outcome Measures

Name	Time	Method
Evaluation of Area Under the Curve From Time 0 to Infinity	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

Secondary Outcome Measures

Name	Time	Method
Treatment-emergent Adverse Events	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).	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.

Trial Locations

Locations (2)

West Coast Clinical Trials; 🇺🇸 Cypress, California, United States

DaVita Clinical Research; 🇺🇸 Minneapolis, Minnesota, United States