title: A Randomized, Controlled Trial of Oral Intestinal Sorbent AST-120 on Renal Function Deterioration in Patients with Advanced Renal Dysfunction.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Ran-Hui
authors.initials: RH
authors.lastname: Cha
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Shin Wook
authors.initials: SW
authors.lastname: Kang
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Cheol Whee
authors.initials: CW
authors.lastname: Park
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Dae Ryong
authors.initials: DR
authors.lastname: Cha
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Ki Young
authors.initials: KY
authors.lastname: Na
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Sung Gyun
authors.initials: SG
authors.lastname: Kim
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Sun Ae
authors.initials: SA
authors.lastname: Yoon
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Sang Youb
authors.initials: SY
authors.lastname: Han
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Jae Hyun
authors.initials: JH
authors.lastname: Chang
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Sue K
authors.initials: SK
authors.lastname: Park
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Chun Soo
authors.initials: CS
authors.lastname: Lim
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material. yonsukim@snu.ac.kr.
authors.forename: Yon Su
authors.initials: YS
authors.lastname: Kim
mesh_terms: D000284:Administration, Oral; D002244:Carbon / Q000008:administration & dosage / Q000494:pharmacology*; D018450:Disease Progression; D005260:Female; D006801:Humans; D007668:Kidney / Q000187:drug effects* / Q000503:physiopathology*; D007676:Kidney Failure, Chronic / Q000503:physiopathology*; D008297:Male; D008875:Middle Aged; D010087:Oxides / Q000008:administration & dosage / Q000494:pharmacology*; D011446:Prospective Studies
chemical_list: D010087:Oxides; D002244:Carbon; C040896:AST 120
keywords: Randomized trial; disease progression; glomerular filtration rate; hospitalization; humans; kidney; kidney function tests; proteinuria; renal insufficiency, chronic; uremic toxin