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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
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv16
  2. Notable Primary endpoints revised (2) Secondary endpoints: 2 to 7 · Study sites revised (106)v15 Show 2 more changesShow less
    • Secondary endpoints: 2 to 7
    • Study sites revised (106)

    See this version in full on ClinicalTrials.gov ↗

  3. Notable Primary endpoints revised (2)v14 See this version in full on ClinicalTrials.gov ↗
  4. Notable Results first posted: Mar 2, 2015 Primary endpoints revised (2) · Secondary endpoints revised (2) · Publications: 2 to 3v13 Show 3 more changesShow less
    • Primary endpoints revised (2)
    • Secondary endpoints revised (2)
    • Publications: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  5. Minor Re-verified, no change to tracked fieldsv12
Show 10 earlier versionsHide 10 earlier versions
  1. Minor Enrollment target: estimated 980 to confirmed 1015v11
  2. Minor Trial status: Active, Not Recruiting to Completedv10
  3. Notable Primary and study completion dates: Jan 2011 to Oct 2011v9
  4. Minor Trial status: Recruiting to Active, Not Recruiting Study sites: 107 to 106v8 Show 1 more changeShow less
    • Study sites: 107 to 106
  5. Minor Enrollment target: 800 to 980 Study sites: 82 to 107 · Secondary endpoints: details revised at 2 of 2 entriesv7 Show 2 more changesShow less
    • Study sites: 82 to 107
    • Secondary endpoints: details revised at 2 of 2 entries
  6. Minor Study sites: 81 to 82 Eligibility criteria expanded, about 20 words · Study title shortened, about 5 wordsv6 Show 2 more changesShow less
    • Eligibility criteria expanded, about 20 words
    • Study title shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  7. Minor Study sites: 57 to 81 Eligibility criteria revisedv5 Show 1 more changeShow less
  8. Minor Study sites: 38 to 57v4
  9. Notable Primary endpoints: 1 to 2 Study sites: 28 to 38 · Primary and study completion dates: Jan 2011 · Interventions: AST-120 (Drug) to AST-120 (Drug), Placebo (Drug) · 3 morev3 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

    See this version in full on ClinicalTrials.gov ↗

  10. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 28 · Start date: Jul 2007v2 Show 2 more changesShow less
    • Study sites: 0 to 28
    • Start date: Jul 2007
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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 Chronic Kidney Disease
Enrollment 1,015 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov