A Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease Including Assessment of Quality of Life (EPPIC-2)

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Kidney Diseases Read More

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 obtained at Screening
• Blood pressure <= 160/90 mmHg at both Screening and Baseline visits. 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