A Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease (EPPIC-1)
NCT ID: NCT00500682
Last Updated: 2026-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1020 participants
INTERVENTIONAL
2007-07-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
9g /day (3 times a day)
AST-120
AST-120
9g /day (3 times a day)
Interventions
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Placebo
9g /day (3 times a day)
AST-120
9g /day (3 times a day)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Kureha Corporation
INDUSTRY
Tanabe Pharma Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Professor
Role: PRINCIPAL_INVESTIGATOR
Information at Mitsubishi Tanabe Pharma Development America, Inc.
Locations
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Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Alhambra, California, United States
Covina, California, United States
Glendale, California, United States
Los Angeles, California, United States
Stamford, Connecticut, United States
Washington D.C., District of Columbia, United States
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
Tampa, Florida, United States
Winter Park, Florida, United States
Kansas City, Kansas, United States
New Orleans, Louisiana, United States
Shreveport, Louisiana, United States
Ypsilanti, Michigan, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Camden, New Jersey, United States
Eatontown, New Jersey, United States
Port Washington, New York, United States
Springfield Gardens, New York, United States
Asheville, North Carolina, United States
Cincinnati, Ohio, United States
Dayton, Ohio, United States
Toledo, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Rock Hill, South Carolina, United States
Nashville, Tennessee, United States
Arlington, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Appleton, Wisconsin, United States
Oshkosh, Wisconsin, United States
Buenos Aires, , Argentina
Córdoba, , Argentina
San Luis, , Argentina
San Miguel de Tucumán, , Argentina
San Pedro, , Argentina
Barao Geraldo-Campinas, , Brazil
Belo Horizonte Minas Gerais, , Brazil
Juiz de Fora, , Brazil
Porto Alegre, , Brazil
Rio de Janeiro, , Brazil
São Paulo, , Brazil
Taubaté, , Brazil
Winnipeg, Manitoba, Canada
Brampton, Ontario, Canada
Kitzhener, Ontario, Canada
Oakville, Ontario, Canada
Scarborough Village, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
České Budějovice, , Czechia
Jihlava, , Czechia
Ostrava - Poruba, , Czechia
Prague, , Czechia
Tábor, , Czechia
Grenoble, , France
Lyon, , France
Nantes, , France
Saint-Lô, , France
Bologna, , Italy
Brescia, , Italy
Como, , Italy
Pavia, , Italy
Aguascalientes, , Mexico
Mexico City, , Mexico
Tijuana, , Mexico
Gdansk, , Poland
Szczecin, , Poland
Torun, , Poland
Warsaw, , Poland
Caguas, , Puerto Rico
Bamaul, , Russia
Kazan', , Russia
Krasnodar, , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Novosibirsk, , Russia
Pyatigorsk, , Russia
Ryazan, , Russia
Saint Petersburg, , Russia
Saratov, , Russia
Smolensk, , Russia
Sochi, , Russia
Stavropol, , Russia
Yekaterinburg, , Russia
Chernivtsi, , Ukraine
Dnipropetrovsk, , Ukraine
Donetsk, , Ukraine
Ivano-Frankivsk, , Ukraine
Kharkiv, , Ukraine
Kiev, , Ukraine
Odesa, , Ukraine
Uzhhorod, , Ukraine
Vinnitsa, , Ukraine
Zhytomyr, , Ukraine
Countries
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References
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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.
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.
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.
Other Identifiers
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KRM-306
Identifier Type: -
Identifier Source: org_study_id
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