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

This study has been completed.
Sponsor:
Collaborator:
Kureha Corporation
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00500682
First received: July 11, 2007
Last updated: June 23, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Chronic Kidney Disease
Drug: Placebo
Drug: AST-120
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • The development of a component of a triple composite endpoint (initiation of dialysis, kidney transplant, or doubling of sCr) [ Time Frame: approximately 42 months ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: approximately 42 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Vitamins and folate levels [ Time Frame: approximately 42 months ] [ Designated as safety issue: Yes ]

Enrollment: 1020
Study Start Date: July 2007
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
9g /day (3 times a day)
Experimental: AST-120 Drug: AST-120
9g /day (3 times a day)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500682

  Hide Study Locations
Locations
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
United States, Florida
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
United States, Kansas
Kansas City, Kansas, United States
United States, Louisiana
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
United States, New Jersey
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
United States, Texas
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
Argentina
Buenos Aires, Argentina
Cordoba, Argentina
San Luis, Argentina
San Pedro, Argentina
Tucuman, Argentina
Brazil
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
Canada, Manitoba
Winnipeg, Manitoba, Canada
Canada, Ontario
Brampton, Ontario, Canada
Kitzhener, Ontario, Canada
Oakville, Ontario, Canada
Scarborough, Ontario, Canada
Toronto, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Czech Republic
Ceske Budejovice, Czech Republic
Jihlava, Czech Republic
Ostrava - Poruba, Czech Republic
Praha, Czech Republic
Tabor, Czech Republic
France
Grenoble, France
Lyon, France
Nantes, France
Saint-Lo, France
Italy
Bologna, Italy
Brescia, Italy
Como, Italy
Pavia, Italy
Mexico
Aguascalientes, Mexico
Mexico City, Mexico
Tijuana, Mexico
Poland
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
Ukraine
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
Investigators
Principal Investigator: Professor Information at Mitsubishi Tanabe Pharma Development America, Inc.
  More Information

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00500682     History of Changes
Other Study ID Numbers: KRM-306
Study First Received: July 11, 2007
Last Updated: June 23, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Russia: Ministry of Health of the Russian Federation
Italy: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Ukraine: Ministry of Health
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Czech Republic: State Institute for Drug Control
Mexico: National Institute of Public Health, Health Secretariat
Poland: Ministry of Health
Brazil: National Health Surveillance Agency

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Kidney Diseases

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

ClinicalTrials.gov processed this record on September 22, 2014