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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)

NCT00501046 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1015

Last updated 2026-01-08

Study results available
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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.

Conditions

Interventions

DRUG

Placebo

9g /day (3 times a day)

DRUG

AST-120

9g /day (3 times a day)

Sponsors & Collaborators

  • Kureha Corporation

    collaborator INDUSTRY

  • Tanabe Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • Professor · Information at Mitsubishi Tanabe Pharma Development America, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Czechia
  • Germany
  • Mexico
  • Poland
  • Puerto Rico
  • Russia
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00501046 on ClinicalTrials.gov