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

End-Stage Renal Disease Clinical Trial

Official title:

An Evaluation of the Pharmacokinetic Profile and Safety and Tolerability of Multiple Doses of 6mg/kg Intravenous Daptomycin in Non-Infected Adult Subjects With End Stage Renal Disease on Hemodialysis or Continuous Ambulatory Peritoneal Dialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00490737
• Other study ID #: 3009-021
• Secondary ID: DAP-REN-07-01
• Status: Completed
• Phase: Phase 1
• First received: June 22, 2007
• Last updated: January 7, 2018
• Start date: August 12, 2007
• Est. completion date: May 12, 2008

Study information

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

Clinical Trial Summary

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

Description:

This is an open label, non-randomized, non-comparative Phase 1 study designed to evaluate the PK profile, safety and tolerability of intravenous ( i.v.) daptomycin. Non-infected subjects with end stage renal disease undergoing hemodialysis (HD) or continuous ambulatory peritoneal dialysis (CAPD) will be enrolled in this in-patient study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 12, 2008
• Est. primary completion date: May 12, 2008
• 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;

• 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.

Exclusion Criteria:

• 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;

• Hospitalized for non-vascular or peritoneal dialysis (PD) access issues within 30 days;

• Subjects with a history of muscular disease (e.g., polymyositis, muscular dystrophy);

• Subjects with a history of neurological disease (e.g., Guillain Barré, multiple sclerosis), except stroke >6 months prior to study entry;

• Intramuscular injection within 7 days of study drug administration;

• Has a moribund clinical condition (i.e., high likelihood of death during the next 3 days);

• Is considered unlikely to comply with study procedures or to return for scheduled post-treatment evaluations;

• Neutropenic subjects with absolute neutrophil count =500 cells/mm3 History of rhabdomyolysis.

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cubist Pharmaceuticals LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics		Study Day 1, 3, 5 and 7 or 8
Secondary	Safety and Tolerability		Study Days 1 through 16 or 17