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A Randomized,Controlled Trial of Oral Intestinal Sorbent AST-120 on Renal Function Deterioration in Patients with Advanced Renal Dysfunction
Authors:Ran-hui Cha  Shin Wook Kang  Cheol Whee Park  Dae Ryong Cha  Ki Young Na  Sung Gyun Kim  Sun Ae Yoon  Sang Youb Han  Jae Hyun Chang  Sue K. Park  Chun Soo Lim  Yon Su Kim
Affiliation:Due to the number of contributing authors, the affiliations are provided in the .
Abstract:

Background and objectives

The notion that oral intestinal sorbent AST-120 slows renal disease progression has not been evaluated thoroughly. In this study, we investigated the long-term effect of AST-120 on renal disease progression (doubling of serum creatinine, eGFR decrease >50%, or initiation of RRT) in patients with advanced CKD.

Design, setting, participants, & measurements

We prospectively recruited 579 patients (CKD stage 3 or 4) from 11 medical centers in Korea from March 4, 2009 to August 31, 2010 and randomized them into an AST-120 arm and a control arm. Patients in the AST-120 arm were given 6 g AST-120 in three divided doses per day, and those in the control arm received only standard conventional treatment (open-label design) for 36 months or until the occurrence of primary outcomes.

Results

Levels of serum and urine indoxyl sulfate and β2-microglobulin decreased throughout the study period in both treatment arms; however, there was not a significant difference in change in uremic toxins in the AST-120 and control arms. The two arms were not different in the occurrence of composite primary outcomes (100 events in 272 individuals in the AST-120 arm and 100 events in 266 individuals in the control arm; hazard ratio, 1.12; 95% confidence interval, 0.85 to 1.48; log-rank P=0.45). The decline in eGFR and change in proteinuria were similar in the two treatment arms over time (Prandomization–time=0.64 and Prandomization–time=0.16, respectively). There was no difference in mortality (nine deaths in the AST-120 arm and 11 deaths in the control arm; log-rank P=0.73) or unplanned hospitalizations (102 in the AST-120 arm and 109 in the control arm; log-rank P=0.76) in the two treatment arms. There was no significant difference of the health–related quality of life score between the two arms.

Conclusions

Long-term use of AST-120 added to standard treatment did not change renal disease progression, proteinuria, mortality, and health–related quality of life in patients with advanced renal dysfunction.
Keywords:Randomized trial   uremic toxin   disease progression   glomerular filtration rate   hospitalization   humans   kidney   kidney function tests   proteinuria   renal insufficiency   chronic
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