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

July 11, 2007
June 23, 2013
July 2007
October 2011   (final data collection date for primary outcome measure)
  • 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 ]
The development of a component of a triple composite endpoint (initiation of dialysis, kidney transplant, or doubling of sCr), safety and tolerability.
Complete list of historical versions of study NCT00500682 on ClinicalTrials.gov Archive Site
  • 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 ]
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.
Not Provided
Not Provided
 
A Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease (EPPIC-1)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Kidney Disease
  • Drug: Placebo
    9g /day (3 times a day)
  • Drug: AST-120
    9g /day (3 times a day)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: AST-120
    Intervention: Drug: AST-120
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1020
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Brazil,   Canada,   Czech Republic,   France,   Italy,   Mexico,   Poland,   Puerto Rico,   Russian Federation,   Ukraine
 
NCT00500682
KRM-306
Yes
Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation
Kureha Corporation
Principal Investigator: Professor Information at Mitsubishi Tanabe Pharma Development America, Inc.
Mitsubishi Tanabe Pharma Corporation
June 2013

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