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2016 ; 11
(4
): 559-67
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A Randomized, Controlled Trial of Oral Intestinal Sorbent AST-120 on Renal
Function Deterioration in Patients with Advanced Renal Dysfunction
#MMPMID26912554
Cha RH
; Kang SW
; Park CW
; Cha DR
; Na KY
; Kim SG
; Yoon SA
; Han SY
; Chang JH
; Park SK
; Lim CS
; Kim YS
Clin J Am Soc Nephrol
2016[Apr]; 11
(4
): 559-67
PMID26912554
show ga
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 ?2-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.