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Study to Evaluate Daptomycin Given During Dialysis and After Dialysis

Primary Purpose

End-stage Renal Disease, Renal Failure Chronic Requiring Hemodialysis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

daptomycin

About this trial

This is an interventional treatment trial for End-stage Renal Disease focused on measuring End-stage renal disease, hemodialysis, chronic renal failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

West Coast Clinical Trials
DaVita Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

9 mg/kg of daptomycin administered during the last 30 minutes of a hemodialysis session.

Post dialysis dosing

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00882557

First Posted

April 15, 2009

Last Updated

January 10, 2018

Sponsor

Cubist Pharmaceuticals LLC

1. Study Identification

Unique Protocol Identification Number

NCT00882557

Brief Title

Study to Evaluate Daptomycin Given During Dialysis and After Dialysis

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

April 29, 2009 (Actual)

Primary Completion Date

July 17, 2009 (Actual)

Study Completion Date

July 17, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cubist Pharmaceuticals LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End-stage Renal Disease, Renal Failure Chronic Requiring Hemodialysis

Keywords

End-stage renal disease, hemodialysis, chronic renal failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

9 mg/kg of daptomycin administered during the last 30 minutes of a hemodialysis session.

Arm Title

Arm Type

Experimental

Arm Description

Post dialysis dosing

Intervention Type

Drug

Intervention Name(s)

daptomycin

Other Intervention Name(s)

Cubicin

Intervention Description

intradialytic: 9 mg/kg during the last 30 minutes of dialysis

Intervention Type

Drug

Intervention Name(s)

daptomycin

Other Intervention Name(s)

Cubicin

Intervention Description

6 mg/kg administered after a hemodialysis session

Primary Outcome Measure Information:

Title

Evaluation of Area Under the Curve From Time 0 to Infinity

Description

Area under the plasma concentration versus time curve from time 0 to infinity for daptomycin doses

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)

Secondary Outcome Measure Information:

Title

Treatment-emergent Adverse Events

Description

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.

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 Pre-specified Outcome Measures:

Title

Maximum Plasma Concentration

Description

Maximum plasma concentration over the entire sampling phase directly obtained from the experimental plasma concentration time data, without interpolation.

Time Frame

Title

Time to Maximum Concentration

Description

Sampling time at which maximum plasma concentration occurred, obtained directly from the experimental plasma concentration time data, without interpolation.

Time Frame

Up to 68 hours post dose

Title

Half-life

Description

Apparent terminal half-life.

Time Frame

Up to 68 hours post dose

Title

Clearance of Daptomycin

Description

Plasma clearance is dose (µg) divided by area under the concentration versus time curve from time 0 to last quantifiable concentration time.

Time Frame

Up to 68 hours post dose

Title

Volume of Distribution

Description

Volume of distribution at steady state (mL) calculated as the product of clearance and mean residence time.

Time Frame

Up to 68 hours post dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alistair Wheeler, MD, MFPM

Organizational Affiliation

Cubist Pharmaceuticals LLC

Official's Role

Study Director

Facility Information:

Facility Name

West Coast Clinical Trials

City

Cypress

State/Province

California

ZIP/Postal Code

90630

Country

United States

Facility Name

DaVita Clinical Research

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55404

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

Learn more about this trial

Study to Evaluate Daptomycin Given During Dialysis and After Dialysis

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