Study to Evaluate Daptomycin Given During Dialysis and After Dialysis

NCT00882557 | Completed Phase 1 Results

• 2 other identifiers: 3009-027DAP-RENID-08-06
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

End-stage Renal Disease; Renal Failure Chronic Requiring Hemodialysis

Keywords

End-stage renal disease; hemodialysis; chronic renal failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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).

Other Outcomes (5)

• Maximum Plasma Concentration

  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)

• Time to Maximum Concentration

  Up to 68 hours post dose

• Half-life

  Up to 68 hours post dose

Study Arms (2)

A

EXPERIMENTAL

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

Drug: daptomycin

B

EXPERIMENTAL

Post dialysis dosing

Drug: daptomycin

Interventions

daptomycin DRUG

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

Also known as: Cubicin

A

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;
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (2)

West Coast Clinical Trials

Cypress, California, 90630, United States

Location

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

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

Results Point of Contact

• Title: Ed Campanaro/Vice President, Clinical Operations
• Organization: Cubist Pharmaceuticals, Inc.

ed.campanaro@cubist.com

781-860-8318

Study Officials

• Alistair Wheeler, MD, MFPM

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2009
• First Posted: April 16, 2009
• Study Start: April 29, 2009
• Primary Completion: July 17, 2009
• Study Completion: July 17, 2009
• Last Updated: February 6, 2018
• Results First Posted: October 25, 2011

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share

Locations

US (2)