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

December 15, 2025 updated by: Tanabe Pharma Corporation

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of AST-120 for Prevention of Chronic Kidney Disease Progression in Patients With Moderate to Severe Chronic Kidney Disease Including Assessment of Quality of Life

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1015

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
      • Córdoba, Argentina
      • San Miguel de Tucumán, Argentina
  • Brazil
      • Belo Horizonte, Brazil
      • Botucatu, Brazil
      • Campinas, Brazil
      • Curitiba, Brazil
      • Ibirapuera, Brazil
      • Porto Alegre, Brazil
      • Rio de Janeiro, Brazil
      • Sorocaba, Brazil
      • São Paulo, Brazil
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Quebec
      • Greenfield Park, Quebec, Canada
      • Montreal, Quebec, Canada
  • Czechia
      • Hradec Králové, Czechia
      • Liberec, Czechia
      • Prague, Czechia
      • Ústí nad Labem, Czechia
  • Germany
      • Hamburg, Germany
      • Kiel, Germany
      • Mainz, Germany
  • Mexico
      • Aguascalientes, Mexico
      • Cuernavaca, Mexico
      • Durango, Mexico
      • Mexico City, Mexico
      • México, Mexico
  • Poland
      • Bialystok, Poland
      • Częstochowa, Poland
      • Lublin, Poland
      • Warsaw, Poland
  • Puerto Rico
      • San Juan, Puerto Rico
  • Russia
      • Arkhangelsk, Russia
      • Chelyabinsk, Russia
      • Kemerovo, Russia
      • Moscow, Russia
      • Novosibirsk, Russia
      • Orenburg, Russia
      • Petrozavodsk, Russia
      • Saint Petersburg, Russia
      • Saratov, Russia
      • Tomsk, Russia
      • Yaroslayl, Russia
      • Yekaterinburg, Russia
  • Spain
      • A Coruña, Spain
      • Asturias, Spain
      • Barcelona, Spain
      • Guadalajara, Spain
      • Madrid, Spain
  • Ukraine
      • Ivano-Frankivsk, Ukraine
      • Kharkiv, Ukraine
      • Kiev, Ukraine
      • Luhansk, Ukraine
      • Lviv, Ukraine
      • Mykolayiv, Ukraine
      • Poltava, Ukraine
      • Ternopil, Ukraine
      • Vinnitsa, Ukraine
      • Zaporizhzhya, Ukraine
  • United States
    • Alabama
      • Tuscaloosa, Alabama, United States
    • Arkansas
      • Hot Springs, Arkansas, United States
    • California
      • Bakersfield, California, United States
      • Glendale, California, United States
      • Los Angeles, California, United States
      • Palo Alto, California, United States
      • Riverside, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Florida
      • Boynton Beach, Florida, United States
      • West Palm Beach, Florida, United States
    • Georgia
      • Augusta, Georgia, United States
      • Macon, Georgia, United States
    • Hawaii
      • Honolulu, Hawaii, United States
    • Illinois
      • Evergreen Park, Illinois, United States
    • Kansas
      • Shawnee Mission, Kansas, United States
    • Louisiana
      • Kenner, Louisiana, United States
      • Shreveport, Louisiana, United States
    • Michigan
      • Pontiac, Michigan, United States
    • Minnesota
      • Brooklyn Center, Minnesota, United States
    • New York
      • Flushing, New York, United States
      • Great Neck, New York, United States
      • New York, New York, United States
      • Williamsville, New York, United States
    • North Carolina
      • Elizabeth City, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
    • Oregon
      • Bend, Oregon, United States
    • Pennsylvania
      • Allentown, Pennsylvania, United States
      • Doylestown, Pennsylvania, United States
      • Lancaster, Pennsylvania, United States
    • Rhode Island
      • Providence, Rhode Island, United States
    • South Carolina
      • Charleston, South Carolina, United States
      • Columbia, South Carolina, United States
      • Orangeburg, South Carolina, United States
      • Sumter, South Carolina, United States
    • Tennessee
      • Knoxville, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • Houston, Texas, United States
    • Virginia
      • Arlington, Virginia, United States
      • Fairfax, Virginia, United States
      • Norfolk, Virginia, United States
      • Richmond, Virginia, United States
      • Suffolk, Virginia, United States
    • Washington
      • Vancouver, Washington, United States
    • West Virginia
      • Morgantown, West Virginia, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 years or older
  • Moderate to severe CKD, not anticipated to require dialysis or renal transplant within the next 6 months
  • Patient survival expected to be no less than one year
  • Serum creatinine in men >= 2.0 mg/dL (>= 177 µmol/L) and <= 5.0 mg/dL (<= 442 µmol/L), and in women >= 1.5 mg/dL (>= 133 µmol/L) and <= 5.0 mg/dL (<= 442 µmol/L) at Screening
  • Urinary total protein to urinary total creatinine ratio must be >= 0.5 on a spot void obtained at Screening
  • Blood pressure <= 160/90 mmHg at both Screening and Baseline visits. In addition, blood pressure, if measured, must have been stable in hypertensive patients over the 3 months prior to Screening, with no more than 1 blood pressure reading > 160/90 mmHg
  • In patients being treated for hypertension, they should be on a stable anti-hypertensive regimen

Exclusion Criteria:

  • Obstructive or reversible cause of kidney disease
  • Nephrotic syndrome defined as a ratio of urinary total protein to urinary creatinine of > 6.0 as measured on a spot void
  • Adult polycystic kidney disease
  • History of previous kidney transplant
  • History of recent (within the past 6 months) accelerated or malignant hypertension
  • Uncontrolled arrhythmia or severe cardiac disease within the past 6 months
  • History of malabsorption, inflammatory bowel disease, hiatal hernia, active peptic ulcer, or severe GI dysmotility, not attributable to the use of a phosphate binder
  • Received any investigational agent or participated in a clinical study within the previous 3 months
  • Presence of any significant medical condition that might create an undue risk with study participation, or significantly confound the collection of safety and efficacy data in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
9g /day (3 times a day)
Experimental: AST-120
Drug: AST-120
9g /day (3 times a day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite of Dialysis Initiation, Kidney Transplantation, and Serum Creatinine Doubling. Number of Participants Meeting the Criteria Are Reported.
Time Frame: Beyond Week 48, a 12-week visit cycle continued until the end of the study or until individual patients reached an endpoint
Beyond Week 48, a 12-week visit cycle continued until the end of the study or until individual patients reached an endpoint
Number of Participants With Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events
Time Frame: Approximately 42 months
Approximately 42 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Who Developed a Component of a Quadruple Composite Endpoint (Initiation of Dialysis, Kidney Transplant, Doubling of sCr, or Death)
Time Frame: approximately 42 months
approximately 42 months
Vitamin A Levels
Time Frame: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 430.293 Days), Final Visit (Mean: 908.486 Days)
Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 430.293 Days), Final Visit (Mean: 908.486 Days)
Vitamin B12 Levels
Time Frame: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 425.112 Days), Final Visit (Mean: 910.988 Days)
Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 425.112 Days), Final Visit (Mean: 910.988 Days)
25-Hydroxyvitamin D Levels
Time Frame: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 429.695 Days), Final Visit (Mean: 908.601 Days)
Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 429.695 Days), Final Visit (Mean: 908.601 Days)
Vitamin E Levels
Time Frame: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 427.067 Days), Final Visit (Mean: 908.715 Days)
Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 427.067 Days), Final Visit (Mean: 908.715 Days)
Vitamin K Levels
Time Frame: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 432.942 Days), Final Visit (Mean: 910.448 Days)
Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 432.942 Days), Final Visit (Mean: 910.448 Days)
Serum Folate Levels
Time Frame: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 420.569 Days), Final Visit (Mean: 909.848 Days)
Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 420.569 Days), Final Visit (Mean: 909.848 Days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanabe Pharma Corporation

Collaborators

Kureha Corporation

Investigators

  • Principal Investigator: Professor, Information at Mitsubishi Tanabe Pharma Development America, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

July 11, 2007

First Submitted That Met QC Criteria

July 11, 2007

First Posted (Estimated)

July 13, 2007

Study Record Updates

Last Update Posted (Estimated)

January 8, 2026

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KRM-307

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Kidney Disease

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe