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 and quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,015
9g /day (3 times a day)
9g /day (3 times a day)
Unnamed facility
Tuscaloosa, Alabama, United States
Unnamed facility
Hot Springs, Arkansas, United States
Unnamed facility
Bakersfield, California, United States
Unnamed facility
Glendale, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
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, Early Term/Discontinuation (Mean: 430.293 Days), Final Visit (Mean: 908.486 Days)
Vitamin B12 Levels
Time frame: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 425.112 Days), Final Visit (Mean: 910.988 Days)
25-Hydroxyvitamin D Levels
Time frame: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 429.695 Days), Final Visit (Mean: 908.601 Days)
Vitamin E Levels
Time frame: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 427.067 Days), Final Visit (Mean: 908.715 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: 432.942 Days), Final Visit (Mean: 910.448 Days)
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: 420.569 Days), Final Visit (Mean: 909.848 Days)
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Palo Alto, California, United States
Unnamed facility
Riverside, California, United States
Unnamed facility
Denver, Colorado, United States
Unnamed facility
Boynton Beach, Florida, United States
Unnamed facility
West Palm Beach, Florida, United States
...and 96 more locations