A Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease (EPPIC-1)

Inclusion Criteria:

- Age 18 years or older

- Moderate to severe CKD, not anticipated to require dialysis or renal transplant within
the next 6 months

- Patient survival expected to be no less than one year

- Serum creatinine in men >= 2.0 mg/dL (>= 177 µmol/L) and <= 5.0 mg/dL (<= 442 µmol/L),
and in women >= 1.5 mg/dL (>= 133 µmol/L) and <= 5.0 mg/dL (<= 442 µmol/L) at
Screening

- Urinary total protein to urinary total creatinine ratio must be >= 0.5 on a spot void
at Screening

- Blood pressure <= 160/90 mmHg at both Screening and Baseline. In addition, blood
pressure, if measured, must have been stable in hypertensive patients over the 3
months prior to Screening, with no more than 1 blood pressure reading > 160/90 mmHg

- In patients being treated for hypertension, they should be on a stable
anti-hypertensive regimen

Exclusion Criteria:

- Obstructive or reversible cause of kidney disease

- Nephrotic syndrome defined as a ratio of urinary total protein to urinary creatinine
of > 6.0 as measured on a spot void

- Adult polycystic kidney disease

- History of previous kidney transplant

- History of recent (within the past 6 months) accelerated or malignant hypertension

- Uncontrolled arrhythmia or severe cardiac disease within the past 6 months

- History of malabsorption, inflammatory bowel disease, hiatal hernia, active peptic
ulcer, or severe GI dysmotility, not attributable to the use of a phosphate binder

- Received any investigational agent or participated in a clinical study within the
previous 3 months

- Presence of any significant medical condition that might create an undue risk with
study participation, or significantly confound the collection of safety and efficacy
data in this study