A Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease (EPPIC-1)
Tracking Information
Start Date ICMJE | July 2007 |
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Estimated Primary Completion Date | January 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: September 27, 2009) |
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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 | Complete list of historical versions of study NCT00500682 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: September 27, 2009) |
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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 ICMJE | A Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease (EPPIC-1) |
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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 |
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 Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Chronic Kidney Disease |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 980 | ||||
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Estimated Completion Date | January 2011 | ||||
Estimated Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Argentina, Brazil, Canada, Czech Republic, France, Italy, Mexico, Poland, Puerto Rico, Russian Federation, Ukraine |
Administrative Information
NCT ID ICMJE | NCT00500682 | ||||
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Responsible Party | Study Project Manager, Mitsubishi Tanabe Pharma Corporation | ||||
Study ID Numbers ICMJE | KRM-306 | ||||
Study Sponsor ICMJE | Mitsubishi Tanabe Pharma Corporation | ||||
Collaborators ICMJE | Kureha Corporation | ||||
Investigators ICMJE |
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Information Provided By | Mitsubishi Tanabe Pharma Corporation |
Source: http://clinicaltrials.gov/