Chronic Kidney DiseasePhase 3NCT00500682
A Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease (EPPIC-1)
A Phase 3 study testing AST-120 in people with Chronic Kidney Disease, run by Tanabe Pharma Corporation at 105 sites in 12 countries.
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
- 1,020 participants
- Where
- 105 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 at Screening
- Blood pressure <= 160/90 mmHg at both Screening and Baseline. 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
105 sites in 12 countries.
105 sites in 12 countries
United States41 sites
Study site
Alhambra, California
Study site
Appleton, Wisconsin
Study site
Arlington, Texas
Study site
Asheville, North Carolina
Study site
Camden, New Jersey
Study site
Cincinnati, Ohio
Study site
Covina, California
Study site
Dallas, Texas
Study site
Dayton, Ohio
Study site
Eatontown, New Jersey
Study site
Glendale, California
Study site
Houston, Texas
Study site
Hudson, Florida
Study site
Kansas City, Kansas
Study site
Kansas City, Missouri
Study site
Little Rock, Arkansas
Study site
Los Angeles, California
Study site
Miami, Florida
Study site
Nashville, Tennessee
Study site
New Orleans, Louisiana
Study site
Ocala, Florida
Study site
Orlando, Florida
Study site
Oshkosh, Wisconsin
Study site
Pembroke Pines, Florida
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Pittsburgh, Pennsylvania
Study site
Port Washington, New York
Study site
Portland, Oregon
Study site
Rock Hill, South Carolina
Study site
San Antonio, Texas
Study site
Shreveport, Louisiana
Study site
Spring Hill, Florida
Study site
Springfield Gardens, New York
Study site
St Louis, Missouri
Study site
Stamford, Connecticut
Study site
Tampa, Florida
Study site
Toledo, Ohio
Study site
Washington D.C., District of Columbia
Study site
Winter Park, Florida
Study site
Ypsilanti, Michigan
Russia14 sites
Study site
Bamaul
Study site
Kazan'
Study site
Krasnodar
Study site
Moscow
Study site
Nizhny Novgorod
Study site
Novosibirsk
Study site
Pyatigorsk
Study site
Ryazan
Study site
Saint Petersburg
Study site
Saratov
Study site
Smolensk
Study site
Sochi
Study site
Stavropol
Study site
Yekaterinburg
Ukraine10 sites
Study site
Chernivtsi
Study site
Dnipropetrovsk
Study site
Donetsk
Study site
Ivano-Frankivsk
Study site
Kharkiv
Study site
Kiev
Study site
Odesa
Study site
Uzhhorod
Study site
Vinnitsa
Study site
Zhytomyr
Brazil7 sites
Study site
Barao Geraldo-Campinas
Study site
Belo Horizonte Minas Gerais
Study site
Juiz de Fora
Study site
Porto Alegre
Study site
Rio de Janeiro
Study site
São Paulo
Study site
Taubaté
Canada7 sites
Study site
Brampton, Ontario
Study site
Kitzhener, Ontario
Study site
Montreal, Quebec
Study site
Oakville, Ontario
Study site
Scarborough Village, Ontario
Study site
Toronto, Ontario
Study site
Winnipeg, Manitoba
Argentina5 sites
Study site
Buenos Aires
Study site
Córdoba
Study site
San Luis
Study site
San Miguel de Tucumán
Study site
San Pedro
Czechia5 sites
Study site
České Budějovice
Study site
Jihlava
Study site
Ostrava - Poruba
Study site
Prague
Study site
Tábor
France4 sites
Study site
Grenoble
Study site
Lyon
Study site
Nantes
Study site
Saint-Lô
Italy4 sites
Study site
Bologna
Study site
Brescia
Study site
Como
Study site
Pavia
Poland4 sites
Study site
Gdansk
Study site
Szczecin
Study site
Torun
Study site
Warsaw
Mexico3 sites
Study site
Aguascalientes
Study site
Mexico City
Study site
Tijuana
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
- 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.
- Conditions
- Chronic Kidney Disease
- 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 group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| AST-120 | Experimental | Not described Receives: Drug: AST-120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Number of Participants With Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events
Measured: Approximately 42 months
Secondary outcomes (7)
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
Vitamin A Levels
Measured: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, Early Term/Discontinuation (Mean: 428.615 Days), Final Visit (Mean: 947.354 Days)
Vitamin B12 Levels
Measured: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, Early Term/Discontinuation (Mean: 428.114 Days), Final Visit (Mean: 947.239 Days)
25-Hydroxyvitamin D Levels
Measured: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, Early Term/Discontinuation (Mean: 427.270 Days), Final Visit (Mean: 946.762 Days)
Vitamin E Levels
Measured: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, Early Term/Discontinuation (Mean: 428.056 Days), Final Visit (Mean: 946.525 Days)
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: 441.826 Days), Final Visit (Mean: 946.463 Days)
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: 423.024 Days), Final Visit (Mean: 946.074 Days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,020 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kureha Corporation
- Responsible party
- Sponsor
- Investigators
- Professor, Principal investigator, Information at Mitsubishi Tanabe Pharma Development America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500682
- Sponsor's protocol ID
- KRM-306
- Status last verified
- Dec 2025
- First submitted
- 11 Jul 2007
- Last updated
- 8 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 25349205Schulman 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 28741050Schulman 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00500682
- Acronym / sponsor ID
- KRM-306
- Conditions
- Chronic Kidney Disease
- Keywords
- Kidney Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,020 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Kureha Corporation
- Study start
- Jul 2007
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 13 Jul 2007 (estimated)
- Results
- Posted 2 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| AST-120 | Experimental | Drug: AST-120 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 at Screening
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo9g /day (3 times a day) | Drug | Placebo |
| AST-1209g /day (3 times a day) | Drug | AST-120 |
Primary outcome
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
Number of Participants With Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events
Time frame: Approximately 42 months
7 secondary outcomes
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
Vitamin A Levels
Time frame: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, Early Term/Discontinuation (Mean: 428.615 Days), Final Visit (Mean: 947.354 Days)
Vitamin B12 Levels
Time frame: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, Early Term/Discontinuation (Mean: 428.114 Days), Final Visit (Mean: 947.239 Days)
25-Hydroxyvitamin D Levels
Time frame: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, Early Term/Discontinuation (Mean: 427.270 Days), Final Visit (Mean: 946.762 Days)
Vitamin E Levels
Time frame: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, Early Term/Discontinuation (Mean: 428.056 Days), Final Visit (Mean: 946.525 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: 441.826 Days), Final Visit (Mean: 946.463 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: 423.024 Days), Final Visit (Mean: 946.074 Days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25349205Schulman 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.
- Derived from this study: PubMed 28741050Schulman 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.
- Derived from this study: PubMed 27716149Schulman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor principal investigator
Information at Mitsubishi Tanabe Pharma Development America, Inc.
105 sites in 12 countries: see every site and its status.
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 105 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 105 sites in United States, Russia, Ukraine, Brazil, Canada 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 NCT00500682, 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.