A randomized, controlled trial of oral intestinal sorbent AST-120 on renal function deterioration in patients with advanced renal dysfunction

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

Research output: Contribution to journalArticle

36 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)559-567
Number of pages9
JournalClinical Journal of the American Society of Nephrology
Volume11
Issue number4
DOIs
Publication statusPublished - 2016 Apr 7

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Randomized Controlled Trials
Kidney
Disease Progression
Proteinuria
Indican
Quality of Life
AST 120
Therapeutics
Mortality
Korea
Serum
Creatinine
Hospitalization
Urine
Confidence Intervals

ASJC Scopus subject areas

  • Epidemiology
  • Critical Care and Intensive Care Medicine
  • Nephrology
  • Transplantation

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A randomized, controlled trial of oral intestinal sorbent AST-120 on renal function deterioration in patients with advanced renal dysfunction. / Cha, Ran Hui; Kang, Shin Wook; Park, Cheol Whee; Cha, Dae-Ryong; Na, Ki Young; Kim, Sung Gyun; Yoon, Sun Ae; Han, Sang Youb; Chang, Jae Hyun; Park, Sue K.; Lim, Chun Soo; Kim, Yon Su.

In: Clinical Journal of the American Society of Nephrology, Vol. 11, No. 4, 07.04.2016, p. 559-567.

Research output: Contribution to journalArticle

Cha, Ran Hui ; Kang, Shin Wook ; Park, Cheol Whee ; Cha, Dae-Ryong ; Na, Ki Young ; Kim, Sung Gyun ; Yoon, Sun Ae ; Han, Sang Youb ; Chang, Jae Hyun ; Park, Sue K. ; Lim, Chun Soo ; Kim, Yon Su. / A randomized, controlled trial of oral intestinal sorbent AST-120 on renal function deterioration in patients with advanced renal dysfunction. In: Clinical Journal of the American Society of Nephrology. 2016 ; Vol. 11, No. 4. pp. 559-567.
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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.",
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AU - Na, Ki Young

AU - Kim, Sung Gyun

AU - Yoon, Sun Ae

AU - Han, Sang Youb

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AU - Lim, Chun Soo

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N2 - 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.

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