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NCT00501046 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Tanabe Pharma Corporation.

Completed
Registry status
Phase 3
Development phase
1,015
Enrollment target

NCT00501046: Completed Phase 3 study, sponsored by Tanabe Pharma Corporation.

NCT00501046 is a Phase 3 study that has completed, run by Tanabe Pharma Corporation. The registered enrollment target is 1,015 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00501046, a Phase 3 study, has completed, sponsored by Tanabe Pharma Corporation.

COMPLETED
Registry status
Phase 3
Development phase
1,015 participants
Enrollment target

Study Summary

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.

Interventions

  • DRUG Placebo
  • DRUG AST-120

Trial Details

FieldValue
Enrollment Target 1,015 participants
Start Date 2007-07
Est. Completion 2011-10
Phase Phase 3
Tanabe Pharma Corporation

7 total trials

What the finished NCT00501046 record still lists

NCT00501046 is an interventional study that assigns participants to a tested intervention. Its 1,015 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00501046 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00501046 about?

NCT00501046 is a clinical study titled "A Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease Including Assessment of Quality of Life (EPPIC-2)". 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 c...

What is the current status of trial NCT00501046?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,015 participants. The study started on 2007-07. Estimated completion is 2011-10.

What interventions are being tested in trial NCT00501046?

The interventions under investigation include: Placebo (DRUG), AST-120 (DRUG).

Who is sponsoring clinical trial NCT00501046?

This trial is sponsored by Tanabe Pharma Corporation, which has 7 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00501046's enrollment target sits among peer trials

1,015 294th of 2000 higher than 1,707 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00501046, the US trial registry maintained by the National Library of Medicine. NCT00501046 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.