The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of FAST PV and mGFR Technology™
Condition: Kidney Diseases; Renal Insufficiency, Chronic; Acute Kidney Injury; Urologic Diseases; Renal Insufficiency
MeSH terms: Kidney Diseases; Acute Kidney Injury; Renal Insufficiency; Renal Insufficiency, Chronic; Urologic Diseases
Study type: Observational

Summary: 
      This is a Phase 2b, prospective, open-label study designed to evaluate the safety,
      tolerability, PK, and PD of FAST PV and mGFR Technology in healthy subjects and patients with
      varying degrees of renal impairment.
    

Detailed description: 
      For Cohorts 1 and 2, administration of the study drug will occur within 21 days of screening.
      Eligible subjects/patients will be admitted to the clinical research unit (CRU) on Day -1, at
      which time assessments will be performed, and results from both screening and Day -1
      (inclusion/exclusion criteria, body weight, height [screening only], body mass index [BMI],
      medical and surgical history, physical examination, vital signs and pulse oximetry, 12 lead
      ECG, clinical laboratory tests, renal function assessment, follicle-stimulating hormone [FSH;
      screening only] and pregnancy test [females only], and urine drugs of abuse and alcohol
      screen) will be reviewed to confirm eligibility.

      For Cohorts 3 and 4, administration of the study drug will occur within 21 days of screening.
      Eligible subjects/patients will be admitted to the CRU on Day 1, at which time assessments
      will be performed and results from both screening and predose administration testing
      (inclusion/exclusion criteria, body weight, height [screening only], BMI, medical and
      surgical history, physical examination, vital signs and pulse oximetry, 12 lead ECG, clinical
      laboratory tests, renal function assessment, FSH and pregnancy test [screening only], and
      urine drugs of abuse and alcohol screen) will be reviewed to confirm eligibility.

      Cohort 1:

      Eligible subjects will receive a single dose of VFI followed 130 minutes later by a 350 mL
      infusion of 5% albumin up to maximum volume of 7 mL/kg over 30 minutes on Day 1. Subjects
      will remain resident in the CRU for at least 24 hours after VFI administration for safety,
      PK, and PD assessments. Subjects will return to the CRU for an end-of-study (EOS) visit on
      Day 21 (± 1 day).

      Cohort 2:

      Eligible subjects will receive a dose of VFI followed 160 minutes later by a single dose of
      Iohexol on Day 1 and a second dose of VFI 24 hours following the initial dose of VFI.
      Subjects will remain resident in the CRU for at least 24 hours after the second VFI
      administration for safety, PK, and PD assessments. Subjects will return to the CRU for
      follow-up visits on Days 5 (± 1 day), 9 (± 1 day), and 16 (± 1 day) and an EOS visit on Day
      22 (± 1 day).

      Cohorts 3 and 4:

      Eligible patients will receive a single dose of VFI followed 160 minutes later by a single
      dose of Iohexol on Day 1. Patients will remain in the CRU through the 12-hour sample
      collection after VFI administration for safety, PK, and PD assessments. . Patients will stay
      at a local hotel near the CRU and will return to the CRU on Day 2 for the 24-hour sample
      collection. Patients will return to the CRU for follow-up visits on Days 4 (± 1 day), 8 (± 1
      day), and 15 (± 1 day) and an EOS visit on Day 21 (± 1 day).
    

Intervention name(s): VFI; Iohexol
Intervention type(s): Device; Device
Intervention description(s): The IV administered visible fluorescent injectate (VFI)™ agent is comprised of a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.; Iohexol is a contrast enhancement agent which, following intravascular injection, is distributed in the extracellular fluid compartment and is excreted unchanged by glomerular filtration.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample