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Can a charcoal pill delay dialysis? large trial tests AST-120

NCT ID NCT00501046

Disease control Sponsor: Tanabe Pharma Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This large Phase 3 trial tested whether AST-120, a spherical carbon adsorbent taken as a pill, can slow the progression of chronic kidney disease. Over 1,000 adults with moderate to severe kidney disease were randomly assigned to receive AST-120 or a placebo, in addition to their standard care. The study measured how long it took for patients to need dialysis, receive a kidney transplant, or have their kidney function worsen significantly.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AST-120 (spherical carbon adsorbent)
What this could lead to
If it works, AST-120 could help delay the need for dialysis or kidney transplant in people with moderate to severe chronic kidney disease.
What could go wrong
This is a completed Phase 3 trial, but results may not show a clear benefit over standard care. The treatment may cause side effects or not slow kidney decline for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,015 people

The number who actually took part.

Start date

Jul 2007

Finished

Oct 2011

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome kidney disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney disease

Contacts and locations

Locations

  • Study site

    Tuscaloosa, Alabama, United States

  • Study site

    Hot Springs, Arkansas, United States

  • Study site

    Bakersfield, California, United States

  • Study site

    Glendale, California, United States

  • Study site

    Los Angeles, California, United States

  • Study site

    Palo Alto, California, United States

  • Study site

    Riverside, California, United States

  • Study site

    Denver, Colorado, United States

  • Study site

    Boynton Beach, Florida, United States

  • Study site

    West Palm Beach, Florida, United States

  • Study site

    Augusta, Georgia, United States

  • Study site

    Macon, Georgia, United States

  • Study site

    Honolulu, Hawaii, United States

  • Study site

    Evergreen Park, Illinois, United States

  • Study site

    Shawnee Mission, Kansas, United States

  • Study site

    Kenner, Louisiana, United States

  • Study site

    Shreveport, Louisiana, United States

  • Study site

    Pontiac, Michigan, United States

  • Study site

    Brooklyn Center, Minnesota, United States

  • Study site

    Flushing, New York, United States

  • Study site

    Great Neck, New York, United States

  • Study site

    New York, New York, United States

  • Study site

    Williamsville, New York, United States

  • Study site

    Elizabeth City, North Carolina, United States

  • Study site

    Cincinnati, Ohio, United States

  • Study site

    Bend, Oregon, United States

  • Study site

    Allentown, Pennsylvania, United States

  • Study site

    Doylestown, Pennsylvania, United States

  • Study site

    Lancaster, Pennsylvania, United States

  • Study site

    Providence, Rhode Island, United States

  • Study site

    Charleston, South Carolina, United States

  • Study site

    Columbia, South Carolina, United States

  • Study site

    Orangeburg, South Carolina, United States

  • Study site

    Sumter, South Carolina, United States

  • Study site

    Knoxville, Tennessee, United States

  • Study site

    Nashville, Tennessee, United States

  • Study site

    Dallas, Texas, United States

  • Study site

    Houston, Texas, United States

  • Study site

    Arlington, Virginia, United States

  • Study site

    Fairfax, Virginia, United States

  • Study site

    Norfolk, Virginia, United States

  • Study site

    Richmond, Virginia, United States

  • Study site

    Suffolk, Virginia, United States

  • Study site

    Vancouver, Washington, United States

  • Study site

    Morgantown, West Virginia, United States

  • Study site

    Milwaukee, Wisconsin, United States

  • Study site

    Buenos Aires, Argentina

  • Study site

    Córdoba, Argentina

  • Study site

    San Miguel de Tucumán, Argentina

  • Study site

    Belo Horizonte, Brazil

  • Study site

    Botucatu, Brazil

  • Study site

    Campinas, Brazil

  • Study site

    Curitiba, Brazil

  • Study site

    Ibirapuera, Brazil

  • Study site

    Porto Alegre, Brazil

  • Study site

    Rio de Janeiro, Brazil

  • Study site

    São Paulo, Brazil

  • Study site

    Sorocaba, Brazil

  • Study site

    Calgary, Alberta, Canada

  • Study site

    Vancouver, British Columbia, Canada

  • Study site

    Greenfield Park, Quebec, Canada

  • Study site

    Montreal, Quebec, Canada

  • Study site

    Hradec Králové, Czechia

  • Study site

    Liberec, Czechia

  • Study site

    Prague, Czechia

  • Study site

    Ústí nad Labem, Czechia

  • Study site

    Hamburg, Germany

  • Study site

    Kiel, Germany

  • Study site

    Mainz, Germany

  • Study site

    Aguascalientes, Mexico

  • Study site

    Cuernavaca, Mexico

  • Study site

    Durango, Mexico

  • Study site

    Mexico City, Mexico

  • Study site

    México, Mexico

  • Study site

    Bialystok, Poland

  • Study site

    Częstochowa, Poland

  • Study site

    Lublin, Poland

  • Study site

    Warsaw, Poland

  • Study site

    San Juan, Puerto Rico

  • Study site

    Arkhangelsk, Russia

  • Study site

    Chelyabinsk, Russia

  • Study site

    Kemerovo, Russia

  • Study site

    Moscow, Russia

  • Study site

    Novosibirsk, Russia

  • Study site

    Orenburg, Russia

  • Study site

    Petrozavodsk, Russia

  • Study site

    Saint Petersburg, Russia

  • Study site

    Saratov, Russia

  • Study site

    Tomsk, Russia

  • Study site

    Yaroslayl, Russia

  • Study site

    Yekaterinburg, Russia

  • Study site

    A Coruña, Spain

  • Study site

    Asturias, Spain

  • Study site

    Barcelona, Spain

  • Study site

    Guadalajara, Spain

  • Study site

    Madrid, Spain

  • Study site

    Ivano-Frankivsk, Ukraine

  • Study site

    Kharkiv, Ukraine

  • Study site

    Kiev, Ukraine

  • Study site

    Luhansk, Ukraine

  • Study site

    Lviv, Ukraine

  • Study site

    Mykolayiv, Ukraine

  • Study site

    Poltava, Ukraine

  • Study site

    Ternopil, Ukraine

  • Study site

    Vinnitsa, Ukraine

  • Study site

    Zaporizhzhya, Ukraine

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