A Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease (EPPIC-1)
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1) To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) added to standard-of-care therapy in moderate to severe Chronic Kidney Disease (CKD), on time to first occurrence of any event of the triple composite outcome of initiation of dialysis, kidney transplant or doubling of serum creatinine (sCr) when compared with placebo; 2) To evaluate the safety and tolerability of long-term AST-120 therapy in patients with CKD; 3) To evaluate the effects of AST-120 versus placebo, on other measures of renal function.
Composite of Dialysis Initiation, Kidney Transplantation, and Serum Creatinine Doubling. Number of Participants Meeting the Criteria Are Reported. [ Time Frame: Beyond Week 48, a 12-week visit cycle continued until the end of the study or until individual patients reached an endpoint ]
Safety and Tolerability [ Time Frame: approximately 42 months ]
Secondary Outcome Measures :
The Development of a Component of a Quadruple Composite Endpoint (Initiation of Dialysis, Kidney Transplant, Doubling of sCr, or Death), Other Measures of Renal Function [ Time Frame: approximately 42 months ]
Vitamins and Folate Levels [ Time Frame: approximately 42 months ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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