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

All Science Journal Classification (ASJC) codes

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

Cite this

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.",
author = "Cha, {Ran Hui} and Kang, {Shin Wook} and Park, {Cheol Whee} and Cha, {Dae Ryong} and Na, {Ki Young} and Kim, {Sung Gyun} and Yoon, {Sun Ae} and Han, {Sang Youb} and Chang, {Jae Hyun} and Park, {Sue K.} and Lim, {Chun Soo} and Kim, {Yon Su}",
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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

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T1 - A randomized, controlled trial of oral intestinal sorbent AST-120 on renal function deterioration in patients with advanced renal dysfunction

AU - Cha, Ran Hui

AU - Kang, Shin Wook

AU - Park, Cheol Whee

AU - Cha, Dae Ryong

AU - Na, Ki Young

AU - Kim, Sung Gyun

AU - Yoon, Sun Ae

AU - Han, Sang Youb

AU - Chang, Jae Hyun

AU - Park, Sue K.

AU - Lim, Chun Soo

AU - Kim, Yon Su

PY - 2016/4/7

Y1 - 2016/4/7

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.

AB - 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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