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

NCT00501046 | Completed Phase 3 Results DMC

• 1 other identifier: KRM-307
• Study Type: interventional
• Target: 1,015
• Locations: 12 countries
• Sites: 106

Brief 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

Chronic Kidney Disease

Keywords

Kidney Diseases

Outcome Measures

Primary Outcomes (2)

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

  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

  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)

  approximately 42 months

• Vitamin A Levels

  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

  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

  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

  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)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

AST-120

EXPERIMENTAL

Drug: AST-120

Interventions

Placebo DRUG

9g /day (3 times a day)

Placebo

AST-120 DRUG

9g /day (3 times a day)

AST-120

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead
• Kureha Corporation: collaborator

Study Sites (106)

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Tuscaloosa, Alabama, United States

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Hot Springs, Arkansas, United States

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Bakersfield, California, United States

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Glendale, California, United States

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Los Angeles, California, United States

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Palo Alto, California, United States

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Riverside, California, United States

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Denver, Colorado, United States

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Boynton Beach, Florida, United States

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West Palm Beach, Florida, United States

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Augusta, Georgia, United States

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Macon, Georgia, United States

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Honolulu, Hawaii, United States

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Evergreen Park, Illinois, United States

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Shawnee Mission, Kansas, United States

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Kenner, Louisiana, United States

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Shreveport, Louisiana, United States

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Pontiac, Michigan, United States

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Brooklyn Center, Minnesota, United States

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Flushing, New York, United States

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Great Neck, New York, United States

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New York, New York, United States

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Williamsville, New York, United States

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Elizabeth City, North Carolina, United States

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Cincinnati, Ohio, United States

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Bend, Oregon, United States

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Allentown, Pennsylvania, United States

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Doylestown, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Orangeburg, South Carolina, United States

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Sumter, South Carolina, United States

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Knoxville, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Arlington, Virginia, United States

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Fairfax, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Suffolk, Virginia, United States

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Vancouver, Washington, United States

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Morgantown, West Virginia, United States

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Milwaukee, Wisconsin, United States

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Buenos Aires, Argentina

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Córdoba, Argentina

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San Miguel de Tucumán, Argentina

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Belo Horizonte, Brazil

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Botucatu, Brazil

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Campinas, Brazil

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Curitiba, Brazil

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Ibirapuera, Brazil

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Porto Alegre, Brazil

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Rio de Janeiro, Brazil

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São Paulo, Brazil

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Sorocaba, Brazil

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Calgary, Alberta, Canada

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Vancouver, British Columbia, Canada

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Greenfield Park, Quebec, Canada

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Montreal, Quebec, Canada

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Hradec Králové, Czechia

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Liberec, Czechia

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Prague, Czechia

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Ústí nad Labem, Czechia

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Hamburg, Germany

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Kiel, Germany

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Mainz, Germany

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Aguascalientes, Mexico

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Cuernavaca, Mexico

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Durango, Mexico

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Mexico City, Mexico

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México, Mexico

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Bialystok, Poland

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Częstochowa, Poland

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Lublin, Poland

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Warsaw, Poland

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San Juan, Puerto Rico

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Arkhangelsk, Russia

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Chelyabinsk, Russia

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Kemerovo, Russia

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Moscow, Russia

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Novosibirsk, Russia

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Orenburg, Russia

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Petrozavodsk, Russia

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Saint Petersburg, Russia

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Saratov, Russia

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Tomsk, Russia

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Yaroslayl, Russia

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Yekaterinburg, Russia

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A Coruña, Spain

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Asturias, Spain

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Barcelona, Spain

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Guadalajara, Spain

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Madrid, Spain

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Ivano-Frankivsk, Ukraine

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Kharkiv, Ukraine

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Kiev, Ukraine

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Luhansk, Ukraine

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Lviv, Ukraine

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Mykolayiv, Ukraine

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Poltava, Ukraine

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Ternopil, Ukraine

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Vinnitsa, Ukraine

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Zaporizhzhya, Ukraine

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Related Publications (3)

• 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.

  PMID: 25349205 RESULT

• 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.

  PMID: 28741050 DERIVED

• 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.

  PMID: 27716149 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Diseases

Interventions

AST 120

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

cti-inq-ml.JP@ml.tanabe-pharma.com

Study Officials

• Professor

  Information at Mitsubishi Tanabe Pharma Development America, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2007
• First Posted: July 13, 2007
• Study Start: July 1, 2007
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 8, 2026
• Results First Posted: March 2, 2015

Record last verified: 2025-12

Locations

PR (1); PL (4); RU (12); ES (5); AR (3); UA (10); US (46); ME (5); CZ (4); BR (9); CA (4); DE (3)