NCT00501046

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,015 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Placebo	9g /day (3 times a day)
DRUG	AST-120	9g /day (3 times a day)

Timeline

• Start date: 2007-07-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2007-07-13
• Last updated: 2026-01-08
• Results posted: 2015-03-02

Locations

106 sites across 12 countries: United States, Argentina, Brazil, Canada, Czechia, Germany, Mexico, Poland, Puerto Rico, Russia, Spain, Ukraine