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


Tracking Information

Start Date  ICMJEJuly 2007
Estimated Primary Completion DateJanuary 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2009)
  • 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 ]
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 HistoryComplete list of historical versions of study NCT00500682 on ClinicalTrials.gov Archive Site
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 [ Time Frame: approximately 42 months ] [ Designated as safety issue: No ]
  • Vitamins and folate levels [ Time Frame: approximately 42 months ] [ Designated as safety issue: Yes ]
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.

Descriptive Information

Brief Title  ICMJEA Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease (EPPIC-1)
Official Title  ICMJEA 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
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.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEChronic Kidney Disease
Intervention  ICMJE
  • Drug: Placebo
    9g /day (3 times a day)
  • Drug: AST-120
    9g /day (3 times a day)
Study Arms / Comparison Groups
  • Placebo: Placebo Comparator
    Intervention: Drug: Placebo
  • AST-120: Experimental
    Intervention: Drug: AST-120

Recruitment Information

Estimated Enrollment  ICMJE980
Estimated Completion DateJanuary 2011
Estimated Primary Completion DateJanuary 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 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
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Information at Mitsubishi Pharma America, IncEPPIC_1@m-pharma.com
Location Countries  ICMJEUnited States,   Argentina,   Brazil,   Canada,   Czech Republic,   France,   Italy,   Mexico,   Poland,   Puerto Rico,   Russian Federation,   Ukraine

Administrative Information

NCT ID  ICMJENCT00500682
Responsible PartyStudy Project Manager, Mitsubishi Tanabe Pharma Corporation
Study ID Numbers  ICMJEKRM-306
Study Sponsor  ICMJEMitsubishi Tanabe Pharma Corporation
Collaborators  ICMJEKureha Corporation
Investigators  ICMJE
Principal Investigator:ProfessorInformation at Mitsubishi Pharma America, Inc.
Information Provided ByMitsubishi Tanabe Pharma Corporation