Plazomicin Study in ESRD Patients Receiving IHD
Condition: End Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to directly characterize the pharmacokinetic (PK) profile of
      plazomicin following administration of a single oral dose before and after IHD in subjects
      with ESRD. This PK assessment will be used to provide appropriate plazomicin dosing
      recommendations for patients with ESRD receiving IHD.
    

Detailed description: 
      This is a Phase 1, single-center, open-label, single-dose study to evaluate the PK of a
      single dose of plazomicin (30-minute IV infusion at 2.5 mg/kg) when administered prior to and
      after IHD in subjects with ESRD.

      The study will consist of a screening period of up to 28 days and two treatment periods, with
      at least a 7-day washout between dosing in each treatment period. The start of the study is
      defined as the date that the first subject is screened following signing of an informed
      consent form (ICF).

      In Period 1 (Week 1), the dosing day will be concomitant with the 3rd weekly IHD session,
      which must be at least 72 hours before the 1st weekly IHD session of the subsequent Week. All
      subjects will receive a single dose of plazomicin (30 minute IV infusion at 2.5 mg/kg) within
      1 hour after IHD is completed. PK samples will be collected at specified time points from 0.6
      hours to 72 hours after completion of the plazomicin infusion. Collection of all PK samples
      must be completed prior to the next scheduled IHD.

      In Period 2 (Week 2), the dosing day will occur on the day of the 3rd weekly IHD session,
      which must be at least 7 days after the first dose and at least 72 hours before the 1st
      weekly IHD session of the subsequent Week. All subjects will receive a single dose of
      plazomicin (30 minute IV infusion at 2.5 mg/kg) before IHD is started. The plazomicin
      infusion should be completed within 30 minutes of IHD initiation. During IHD, the total
      dialysate will be collected in a large collection container and pooled at 1-hour intervals
      (0-1, 1-2, 2-3, etc. for the duration of the IHD session). From each hourly interval
      (including any partial interval at end of dialysis), an aliquot sample of dialysate will be
      collected for PK analysis. PK samples will be collected at specified time points from 0.6
      hours to 72 hours after completion of the plazomicin infusion. Collection of all PK samples
      must be completed prior to the next scheduled IHD.

      Safety assessments will include physical examination findings, vital signs (blood pressure,
      pulse rate, respiration rate, and oral temperature), clinical laboratory evaluations, and
      monitoring of adverse events (AEs). Adverse events will be assessed from the time the subject
      signs the ICF until exit from the study.

      The site will attempt to contact all subjects (including subjects who terminate the study
      early) via phone call approximately 14 days after the last dose of study drug to determine if
      any AE has occurred since the last study visit. Subjects reporting AEs may be asked to return
      to the site for further assessment.
    

Intervention name(s): Plazomicin Injection
Intervention type(s): Drug
Intervention description(s): single dose of plazomicin
Other intervention name(s): Zemdri
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment