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

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.
 
ClinicalTrials.gov Identifier: NCT00501046
Recruitment Status : Completed
First Posted : July 13, 2007
Results First Posted : March 2, 2015
Last Update Posted : March 20, 2015
Sponsor:
Collaborator:
Kureha Corporation
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Tracking Information
First Submitted Date  ICMJE July 11, 2007
First Posted Date  ICMJE July 13, 2007
Results First Submitted Date  ICMJE February 15, 2015
Results First Posted Date  ICMJE March 2, 2015
Last Update Posted Date March 20, 2015
Study Start Date  ICMJE July 2007
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2015)
  • 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 ]
  • Safety and Tolerability [ Time Frame: approximately 42 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 11, 2007)
The development of a component of a triple composite endpoint (initiation of dialysis, kidney transplant, or doubling of sCr), safety and tolerability.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2009)
  • 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 and (QOL: Exploratory) [ Time Frame: approximately 42 months ]
  • Vitamins and Folate Levels [ Time Frame: approximately 42 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2007)
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, vitamins and folate levels, (QOL: exploratory).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease Including Assessment of Quality of Life (EPPIC-2)
Official Title  ICMJE 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 Including Assessment of Quality of Life
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Kidney Disease
Intervention  ICMJE
  • Drug: Placebo
    9g /day (3 times a day)
  • Drug: AST-120
    9g /day (3 times a day)
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: AST-120
    Intervention: Drug: AST-120
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 1, 2012)
1015
Original Estimated Enrollment  ICMJE
 (submitted: July 11, 2007)
800
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Brazil,   Canada,   Czech Republic,   Germany,   Mexico,   Poland,   Puerto Rico,   Russian Federation,   Spain,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00501046
Other Study ID Numbers  ICMJE KRM-307
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mitsubishi Tanabe Pharma Corporation
Study Sponsor  ICMJE Mitsubishi Tanabe Pharma Corporation
Collaborators  ICMJE Kureha Corporation
Investigators  ICMJE
Principal Investigator: Professor Information at Mitsubishi Tanabe Pharma Development America, Inc.
PRS Account Mitsubishi Tanabe Pharma Corporation
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP