FAST GFR: Pilot Study to Evaluate the Safety of the FAST GFR Test in Patients.

Inclusion Criteria for Groups 1-3:

• Female subjects: women must have a negative urine pregnancy test at screening and before dosing on Visit 2 and be either confirmed by the Investigator to be infertile or using a reliable method of contraception Male subjects: reproductively active men must agree to either practice abstinence or utilize adequate contraception.
• Ages 19 to 75
• Subject's screening must fall into one of the available categories of estimated glomerular filtration rate (eGFR) renal function: ≥ 60 mL/min for stage normal function; 30-59 mL/min for stage 3, moderate CKD; 15-29 mL/min for stage 4, severe CKD,
• Patients must not be on inotropes or vasopressors, and must be absent of significant hemodynamic instabilities.
• Patients must have ceased use of the following:
• nonsteroidal anti-inflammatory drugs - 6 days prior,
• herbal supplements - 6 days prior to testing and
• cimetidine and trimethoprim - 14 days prior to testing.
• Ability to comply with study conditions

Inclusion Criteria for Group 4:

• Female subjects; women must have a negative urine pregnancy test at screening and before dosing on Visit 2 and be either confirmed by the Investigator to be infertile or using a reliable method of contraception.

Male subjects: reproductively active men must agree to either practice abstinence or utilize adequate contraception.

• Ages 19 to 75
• For cohort 4: patients diagnosed with [either RIFLE stage I or Acute Kidney Injury Network (AKIN) stage 2 AKI]
• Patients must not be on inotropes or vasopressors, and must be absent of significant hemodynamic instabilities.
• Patients must be without evidence of clinically significant liver dysfunction
• Ability to comply with study conditions

Exclusion Criteria for Groups 1-3:

• Positive history of any clinically significant allergic or negative reactions, side effects, or anaphylaxis to sulfa, iodine, dyes, shellfish, isotopes or dextran molecules
• Previous history of nephrectomy or kidney transplant
• A body weight below 40kg
• A body mass index 40
• Subjects using Coumadin (Warfarin) who have an INR >4 at Screening or pre-dose on Visit 2
• Past history of liver disease or screening Liver Function tests which exceed 1.5 times the upper limit of normal or an albumin of 40
• Current use of prescribed anticoagulants
• Past history of liver disease or screening Liver Function tests which exceed 1.5 times the upper limit of normal or an albumin of < 2mg/dl.
• Received blood, donated blood, have clinically significant on-going bleeding, changing haemoglobin, or experienced significant blood loss within 2 weeks of dosing
• Subjects with a supine blood pressure after resting for at least 5 minutes outside the 90-145 (systolic) or mmHg or 50-95 mmHg (diastolic) range
• Subjects with a supine (ECG) heart rate outside 45-105 beats/min after resting for at least 5 minutes.
• Subjects with a known or suspected history of drug or alcohol abuse within 6 months prior to admission, who have a positive drug test or alcohol test, or who have consumed alcohol within 24 of testing
• Subjects who had a positive result for Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibody (HCVAb) screen.
• Subjects who have been diagnosed with acquired immune deficiency syndrome (AIDS), or test positive for human immunodeficiency virus (HIV).
• Subjects who participated in another clinical trial less than 1 month prior to dosing, or who are currently enrolled in another clinical trial.
• Subjects who have any condition that:
• Would make him/her, in the opinion of the Investigator, unsuitable for the study
• Whose condition is likely to deteriorate
• Who, in the opinion of the Investigator, is not likely to complete the study for any reason