A Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease (EPPIC-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00500682
Recruitment Status : Completed
First Posted : July 13, 2007
Results First Posted : March 2, 2015
Last Update Posted : March 20, 2015
Kureha Corporation
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Placebo Drug: AST-120 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1020 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : July 2007
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

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)

Primary Outcome Measures :
  1. 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 ]
  2. Safety and Tolerability [ Time Frame: approximately 42 months ]

Secondary Outcome Measures :
  1. The Development of a Component of a Quadruple Composite Endpoint (Initiation of Dialysis, Kidney Transplant, Doubling of sCr, or Death), Other Measures of Renal Function [ Time Frame: approximately 42 months ]
  2. Vitamins and Folate Levels [ Time Frame: approximately 42 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00500682

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United States, Arizona
Phoenix, Arizona, United States
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
Alhambra, California, United States
Covina, California, United States
Glendale, California, United States
Los Angeles, California, United States
United States, Connecticut
Stamford, Connecticut, United States
United States, District of Columbia
Washington, District of Columbia, United States
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Hudson, Florida, United States
Miami, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
Pembroke Pines, Florida, United States
Spring Hill, Florida, United States
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Winter Park, Florida, United States
United States, Kansas
Kansas City, Kansas, United States
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New Orleans, Louisiana, United States
Shreveport, Louisiana, United States
United States, Michigan
Ypsilanti, Michigan, United States
United States, Missouri
Kansas City, Missouri, United States
St. Louis, Missouri, United States
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Camden, New Jersey, United States
Eatontown, New Jersey, United States
United States, New York
Port Washington, New York, United States
Springfield Gardens, New York, United States
United States, North Carolina
Asheville, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Dayton, Ohio, United States
Toledo, Ohio, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Rock Hill, South Carolina, United States
United States, Tennessee
Nashville, Tennessee, United States
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Arlington, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
United States, Wisconsin
Appleton, Wisconsin, United States
Oshkosk, Wisconsin, United States
Buenos Aires, Argentina
Cordoba, Argentina
San Luis, Argentina
San Pedro, Argentina
Tucuman, Argentina
Barao Geraldo-Campinas, Brazil
Belo Horizonte Minas Gerais, Brazil
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Canada, Manitoba
Winnipeg, Manitoba, Canada
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Brampton, Ontario, Canada
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Scarborough, Ontario, Canada
Toronto, Ontario, Canada
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Montreal, Quebec, Canada
Czech Republic
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Ostrava - Poruba, Czech Republic
Praha, Czech Republic
Tabor, Czech Republic
Grenoble, France
Lyon, France
Nantes, France
Saint-Lo, France
Bologna, Italy
Brescia, Italy
Como, Italy
Pavia, Italy
Aguascalientes, Mexico
Mexico City, Mexico
Tijuana, Mexico
Gdansk, Poland
Szczecin, Poland
Torun, Poland
Warszawa, Poland
Puerto Rico
Caguas, Puerto Rico
Russian Federation
Bamaul, Russian Federation
Ekaterinburg, Russian Federation
Kazan, Russian Federation
Krasnodar, Russian Federation
Moscow, Russian Federation
Nizhniy Novgorod, Russian Federation
Novosibirsk, Russian Federation
Pyatigorsk, Russian Federation
Ryazan, Russian Federation
Saratov, Russian Federation
Smolensk, Russian Federation
Sochi, Russian Federation
St. Petersburg, Russian Federation
Stavropol, Russian Federation
Chernovtsy, Ukraine
Dnipropetrovsk, Ukraine
Donetsk, Ukraine
Ivano-Frankivsk, Ukraine
Kharkov, Ukraine
Kiev, Ukraine
Odessa, Ukraine
Uzhgorod, Ukraine
Vinnitsa, Ukraine
Zhytomir, Ukraine
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Kureha Corporation
Principal Investigator: Professor Information at Mitsubishi Tanabe Pharma Development America, Inc.

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mitsubishi Tanabe Pharma Corporation Identifier: NCT00500682     History of Changes
Other Study ID Numbers: KRM-306
First Posted: July 13, 2007    Key Record Dates
Results First Posted: March 2, 2015
Last Update Posted: March 20, 2015
Last Verified: March 2015

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Kidney Diseases

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency