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Randomized Controlled Trial
. 2016 Apr 7;11(4):559-67.
doi: 10.2215/CJN.12011214. Epub 2016 Feb 9.

A Randomized, Controlled Trial of Oral Intestinal Sorbent AST-120 on Renal Function Deterioration in Patients with Advanced Renal Dysfunction

Ran-Hui Cha  1 , Shin Wook Kang  1 , Cheol Whee Park  1 , Dae Ryong Cha  1 , Ki Young Na  1 , Sung Gyun Kim  1 , Sun Ae Yoon  1 , Sang Youb Han  1 , Jae Hyun Chang  1 , Sue K Park  1 , Chun Soo Lim  1 , Yon Su Kim  2
Affiliations
Randomized Controlled Trial

A Randomized, Controlled Trial of Oral Intestinal Sorbent AST-120 on Renal Function Deterioration in Patients with Advanced Renal Dysfunction

Ran-Hui Cha et al. Clin J Am Soc Nephrol. .

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; disease progression; glomerular filtration rate; hospitalization; humans; kidney; kidney function tests; proteinuria; renal insufficiency, chronic; uremic toxin.

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Figures

Figure 1.
Figure 1.
Diagram of participant enrollment and analysis in the Kremezin Study against Renal Disease Progression in Korea, 2009–2013.
Figure 2.
Figure 2.
Occurrence of composite primary outcomes in each treatment arm. Log-rank P=0.45.
Figure 3.
Figure 3.
Change of eGFR over time. Absolute change of eGFR from intention-to-treat participants (Prandomization=0.02; Prandomization–time=0.64). Vertical lines and white symbols indicate 95% confidence intervals.
See this image and copyright information in PMC

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