drugset / Trial / NCT00860431

Kremezin Study Against Renal Disease Progression in Korea

NCT00860431

RandomizedParallel-groupOpen-labelTreatment

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 III-IV), on time to first occurrence of any event of the triple composite outcome of initiation of renal replacement therapy, decline of eGFR 50% or more or doubling of serum creatinine (sCr) when compared with standard-of-care group; 2. To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) to GFR and proteinuria; 3. To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) to health related quality of life; 4. To evaluate the safety and tolerability of long-term AST-120 therapy in patients with CKD; 5. To evaluate the all-cause mortality and hospitalization apart from those planned for operation and intervention)

Timeline

Start
2009-03
Primary completion
2013-09
Completion
2013-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Activated Charcoal Other / unclassified 6 g