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Chronic Kidney DiseasePhase 3NCT00501046

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 testing AST-120 in people with Chronic Kidney Disease, run by Tanabe Pharma Corporation at 106 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Kidney Disease
What is being tested?
AST-120
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,015 participants
Where
106 sitesin 12 countries
Study dates
Jul 2007to Oct 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

106 sites in 12 countries.

106 sites in 12 countries

United States46 sites

  • Study site

    Allentown, Pennsylvania

  • Study site

    Arlington, Virginia

  • Study site

    Augusta, Georgia

  • Study site

    Bakersfield, California

  • Study site

    Bend, Oregon

  • Study site

    Boynton Beach, Florida

  • Study site

    Brooklyn Center, Minnesota

  • Study site

    Charleston, South Carolina

  • Study site

    Cincinnati, Ohio

  • Study site

    Columbia, South Carolina

  • Study site

    Dallas, Texas

  • Study site

    Denver, Colorado

  • Study site

    Doylestown, Pennsylvania

  • Study site

    Elizabeth City, North Carolina

  • Study site

    Evergreen Park, Illinois

  • Study site

    Fairfax, Virginia

  • Study site

    Flushing, New York

  • Study site

    Glendale, California

  • Study site

    Great Neck, New York

  • Study site

    Honolulu, Hawaii

  • Study site

    Hot Springs, Arkansas

  • Study site

    Houston, Texas

  • Study site

    Kenner, Louisiana

  • Study site

    Knoxville, Tennessee

  • Study site

    Lancaster, Pennsylvania

  • Study site

    Los Angeles, California

  • Study site

    Macon, Georgia

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Morgantown, West Virginia

  • Study site

    Nashville, Tennessee

  • Study site

    New York, New York

  • Study site

    Norfolk, Virginia

  • Study site

    Orangeburg, South Carolina

  • Study site

    Palo Alto, California

  • Study site

    Pontiac, Michigan

  • Study site

    Providence, Rhode Island

  • Study site

    Richmond, Virginia

  • Study site

    Riverside, California

  • Study site

    Shawnee Mission, Kansas

  • Study site

    Shreveport, Louisiana

  • Study site

    Suffolk, Virginia

  • Study site

    Sumter, South Carolina

  • Study site

    Tuscaloosa, Alabama

  • Study site

    Vancouver, Washington

  • Study site

    West Palm Beach, Florida

  • Study site

    Williamsville, New York

Other trials in United States

Russia12 sites

  • Study site

    Arkhangelsk

  • Study site

    Chelyabinsk

  • Study site

    Kemerovo

  • Study site

    Moscow

  • Study site

    Novosibirsk

  • Study site

    Orenburg

  • Study site

    Petrozavodsk

  • Study site

    Saint Petersburg

  • Study site

    Saratov

  • Study site

    Tomsk

  • Study site

    Yaroslayl

  • Study site

    Yekaterinburg

Other trials in Russia

Ukraine10 sites

  • Study site

    Ivano-Frankivsk

  • Study site

    Kharkiv

  • Study site

    Kiev

  • Study site

    Luhansk

  • Study site

    Lviv

  • Study site

    Mykolayiv

  • Study site

    Poltava

  • Study site

    Ternopil

  • Study site

    Vinnitsa

  • Study site

    Zaporizhzhya

Other trials in Ukraine

Brazil9 sites

  • Study site

    Belo Horizonte

  • Study site

    Botucatu

  • Study site

    Campinas

  • Study site

    Curitiba

  • Study site

    Ibirapuera

  • Study site

    Porto Alegre

  • Study site

    Rio de Janeiro

  • Study site

    São Paulo

  • Study site

    Sorocaba

Other trials in Brazil

Mexico5 sites

  • Study site

    Aguascalientes

  • Study site

    Cuernavaca

  • Study site

    Durango

  • Study site

    México

  • Study site

    Mexico City

Other trials in Mexico

Spain5 sites

  • Study site

    A Coruña

  • Study site

    Asturias

  • Study site

    Barcelona

  • Study site

    Guadalajara

  • Study site

    Madrid

Other trials in Spain

Canada4 sites

  • Study site

    Calgary, Alberta

  • Study site

    Greenfield Park, Quebec

  • Study site

    Montreal, Quebec

  • Study site

    Vancouver, British Columbia

Other trials in Canada

Czechia4 sites

  • Study site

    Hradec Králové

  • Study site

    Liberec

  • Study site

    Prague

  • Study site

    Ústí nad Labem

Other trials in Czechia

Poland4 sites

  • Study site

    Bialystok

  • Study site

    Częstochowa

  • Study site

    Lublin

  • Study site

    Warsaw

Other trials in Poland

Argentina3 sites

  • Study site

    Buenos Aires

  • Study site

    Córdoba

  • Study site

    San Miguel de Tucumán

Other trials in Argentina

Germany3 sites

  • Study site

    Hamburg

  • Study site

    Kiel

  • Study site

    Mainz

Other trials in Germany

Puerto Rico1 site

  • Study site

    San Juan

Other trials in Puerto Rico

About this study

Official title: 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.
Being tested
Placebo, AST-120
Keywords
Kidney Diseases
Medical subject headings
Renal Insufficiency, Chronic, Kidney Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    9g /day (3 times a day)

  • AST-120Drug

    9g /day (3 times a day)

Study groups in NCT00501046
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
AST-120ExperimentalNot described
Receives: Drug: AST-120

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite of Dialysis Initiation, Kidney Transplantation, and Serum Creatinine Doubling. Number of Participants Meeting the Criteria Are Reported.

    Measured: Beyond Week 48, a 12-week visit cycle continued until the end of the study or until individual patients reached an endpoint

  2. Number of Participants With Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events

    Measured: Approximately 42 months

Secondary outcomes (7)

  1. Number of Participants Who Developed a Component of a Quadruple Composite Endpoint (Initiation of Dialysis, Kidney Transplant, Doubling of sCr, or Death)

    Measured: approximately 42 months

  2. Vitamin A Levels

    Measured: 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)

  3. Vitamin B12 Levels

    Measured: 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)

  4. 25-Hydroxyvitamin D Levels

    Measured: 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)

  5. Vitamin E Levels

    Measured: 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)

  6. Vitamin K Levels

    Measured: 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)

  7. Serum Folate Levels

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionOct 2011
  4. Study completionOct 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,015 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00501046
Sponsor's protocol ID
KRM-307
Status last verified
Dec 2025
First submitted
11 Jul 2007
Last updated
8 Jan 2026
Data monitoring committee
Yes

Publications

  • Schulman G, Berl T, Beck GJ, Remuzzi G, Ritz E, Arita K, Kato A, Shimizu M. Randomized Placebo-Controlled EPPIC Trials of AST-120 in CKD. J Am Soc Nephrol. 2015 Jul;26(7):1732-46. doi: 10.1681/ASN.2014010042. Epub 2014 Oct 27.

    PubMed 25349205

  • Schulman G, Berl T, Beck GJ, Remuzzi G, Ritz E, Shimizu M, Kikuchi M, Shobu Y. Risk factors for progression of chronic kidney disease in the EPPIC trials and the effect of AST-120. Clin Exp Nephrol. 2018 Apr;22(2):299-308. doi: 10.1007/s10157-017-1447-0. Epub 2017 Jul 24.

    PubMed 28741050

  • Schulman G, Berl T, Beck GJ, Remuzzi G, Ritz E, Shimizu M, Shobu Y, Kikuchi M. The effects of AST-120 on chronic kidney disease progression in the United States of America: a post hoc subgroup analysis of randomized controlled trials. BMC Nephrol. 2016 Sep 30;17(1):141. doi: 10.1186/s12882-016-0357-9.

    PubMed 27716149

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AST-120 in people with Chronic Kidney Disease, run by Tanabe Pharma Corporation at 106 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in United States, Russia, Ukraine, Brazil, Mexico and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00501046, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.

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