A Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease Including Assessment of Quality of Life (EPPIC-2)
NCT ID: NCT00501046
Last Updated: 2026-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1015 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 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
* 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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Tuscaloosa, Alabama, United States
Hot Springs, Arkansas, United States
Bakersfield, California, United States
Glendale, California, United States
Los Angeles, California, United States
Palo Alto, California, United States
Riverside, California, United States
Denver, Colorado, United States
Boynton Beach, Florida, United States
West Palm Beach, Florida, United States
Augusta, Georgia, United States
Macon, Georgia, United States
Honolulu, Hawaii, United States
Evergreen Park, Illinois, United States
Shawnee Mission, Kansas, United States
Kenner, Louisiana, United States
Shreveport, Louisiana, United States
Pontiac, Michigan, United States
Brooklyn Center, Minnesota, United States
Flushing, New York, United States
Great Neck, New York, United States
New York, New York, United States
Williamsville, New York, United States
Elizabeth City, North Carolina, United States
Cincinnati, Ohio, United States
Bend, Oregon, United States
Allentown, Pennsylvania, United States
Doylestown, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Providence, Rhode Island, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Orangeburg, South Carolina, United States
Sumter, South Carolina, United States
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
Arlington, Virginia, United States
Fairfax, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Suffolk, Virginia, United States
Vancouver, Washington, United States
Morgantown, West Virginia, United States
Milwaukee, Wisconsin, United States
Buenos Aires, , Argentina
Córdoba, , Argentina
San Miguel de Tucumán, , Argentina
Belo Horizonte, , Brazil
Botucatu, , Brazil
Campinas, , Brazil
Curitiba, , Brazil
Ibirapuera, , Brazil
Porto Alegre, , Brazil
Rio de Janeiro, , Brazil
São Paulo, , Brazil
Sorocaba, , Brazil
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Greenfield Park, Quebec, Canada
Montreal, Quebec, Canada
Hradec Králové, , Czechia
Liberec, , Czechia
Prague, , Czechia
Ústí nad Labem, , Czechia
Hamburg, , Germany
Kiel, , Germany
Mainz, , Germany
Aguascalientes, , Mexico
Cuernavaca, , Mexico
Durango, , Mexico
Mexico City, , Mexico
México, , Mexico
Bialystok, , Poland
Częstochowa, , Poland
Lublin, , Poland
Warsaw, , Poland
San Juan, , Puerto Rico
Arkhangelsk, , Russia
Chelyabinsk, , Russia
Kemerovo, , Russia
Moscow, , Russia
Novosibirsk, , Russia
Orenburg, , Russia
Petrozavodsk, , Russia
Saint Petersburg, , Russia
Saratov, , Russia
Tomsk, , Russia
Yaroslayl, , Russia
Yekaterinburg, , Russia
A Coruña, , Spain
Asturias, , Spain
Barcelona, , Spain
Guadalajara, , Spain
Madrid, , Spain
Ivano-Frankivsk, , Ukraine
Kharkiv, , Ukraine
Kiev, , Ukraine
Luhansk, , Ukraine
Lviv, , Ukraine
Mykolayiv, , Ukraine
Poltava, , Ukraine
Ternopil, , Ukraine
Vinnitsa, , Ukraine
Zaporizhzhya, , 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-307
Identifier Type: -
Identifier Source: org_study_id
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