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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,020
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
Number of Participants With Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events
Time frame: Approximately 42 months
Number of Participants Who Developed a Component of a Quadruple Composite Endpoint (Initiation of Dialysis, Kidney Transplant, Doubling of sCr, or Death)
Time frame: Approximately 42 months
Vitamin A Levels
Time frame: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, Early Term/Discontinuation (Mean: 428.615 Days), Final Visit (Mean: 947.354 Days)
Vitamin B12 Levels
Time frame: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, Early Term/Discontinuation (Mean: 428.114 Days), Final Visit (Mean: 947.239 Days)
25-Hydroxyvitamin D Levels
Time frame: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, Early Term/Discontinuation (Mean: 427.270 Days), Final Visit (Mean: 946.762 Days)
Vitamin E Levels
Time frame: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, Early Term/Discontinuation (Mean: 428.056 Days), Final Visit (Mean: 946.525 Days)
Vitamin K Levels
Time frame: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 441.826 Days), Final Visit (Mean: 946.463 Days)
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Unnamed facility
Phoenix, Arizona, United States
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Little Rock, Arkansas, United States
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Alhambra, California, United States
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Covina, California, United States
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Glendale, California, United States
Unnamed facility
Los Angeles, California, United States
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Stamford, Connecticut, United States
Unnamed facility
Washington D.C., District of Columbia, United States
Unnamed facility
Hudson, Florida, United States
Unnamed facility
Miami, Florida, United States
...and 95 more locations
Serum Folate Levels
Time frame: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 423.024 Days), Final Visit (Mean: 946.074 Days)