MinorEnrollment target: estimated 980 to confirmed 1020v12
MinorTrial status: Active, Not Recruiting to Completedv11
NotablePrimary and study completion dates: Jan 2011 to Oct 2011v10
MinorTrial status: Recruiting to Active, Not Recruiting
Study sites: 107 to 105
v9
MinorStudy sites: 106 to 107v8
MinorEnrollment target: 800 to 980
Study sites: 85 to 106
Secondary endpoints: details revised at 2 of 2 entries
v7
MinorStudy sites: 84 to 85
Eligibility criteria expanded, about 20 words
Study title shortened, about 5 words
v6
MinorStudy sites: 58 to 84v5
MinorStudy sites: 34 to 58v4
NotablePrimary endpoints: 1 to 2v3Show 6 more changesShow less
Study sites: 23 to 34
Primary and study completion dates: Jan 2011
Interventions: AST-120 (Drug) to AST-120 (Drug), Placebo (Drug)
Secondary endpoints: 1 to 2
Study arms: 0 to 2
Eligibility criteria expanded, about 4 words
NotableTrial status: Not Yet Recruiting to Recruiting
Study sites: 0 to 23
Start date: Jul 2007
v2
Study First Submitted
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.