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

StatusCompleted
PhasePhase 3
Started

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Record History

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  1. Re-verified, no change to tracked fieldsv16
  2. Primary endpoints revised (2)
    • Secondary endpoints: 2 to 7
    • Study sites revised (106)
    v15
  3. Primary endpoints revised (2)v14
  4. Results first posted: Mar 2, 2015
    • Primary endpoints revised (2)
    • Secondary endpoints revised (2)
    • Publications: 2 to 3
    v13
  5. Re-verified, no change to tracked fieldsv12
Show 10 earlier versionsHide 10 earlier versions
  1. Enrollment target: estimated 980 to confirmed 1015v11
  2. Trial status: Active, Not Recruiting to Completedv10
  3. Primary and study completion dates: Jan 2011 to Oct 2011v9
  4. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 107 to 106
    v8
  5. Enrollment target: 800 to 980
    • Study sites: 82 to 107
    • Secondary endpoints: details revised at 2 of 2 entries
    v7
  6. Study sites: 81 to 82
    • Eligibility criteria expanded, about 20 words
    • Study title shortened, about 5 words
    v6
  7. Study sites: 57 to 81
    • Eligibility criteria revised
    v5
  8. Study sites: 38 to 57v4
  9. Primary endpoints: 1 to 2v3 Show 6 more changesShow less
    • Study sites: 28 to 38
    • 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
  10. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 28
    • Start date: Jul 2007
    v2
  1. 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 and quality of life.
Trial Details
NCT Number NCT00501046
Lead Sponsor Tanabe Pharma Corporation
Collaborators: Kureha Corporation
Conditions
(from sponsor)		 Chronic Kidney Disease
Related terms Kidney Diseases, Renal Insufficiency, Chronic
Enrollment 1,015 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov