Comparison of Different Types of Oral Adsorbent Therapy in Patients with Chronic Kidney Disease: A Multicenter, Randomized, Phase IV Clinical Trial

Youn Kyung Kee, Sang Youb Han, Duk Hee Kang, Jung Woo Noh, Kyung Hwan Jeong, Gheun Ho Kim, Yang Wook Kim, Beom Seok Kim, Youn Kyung Kee, Sang Youb Han, Duk Hee Kang, Jung Woo Noh, Kyung Hwan Jeong, Gheun Ho Kim, Yang Wook Kim, Beom Seok Kim

Abstract

Purpose: Oral adsorbents delay disease progression and improve uremic symptoms in patients with chronic kidney disease (CKD). DW-7202 is a newly developed oral adsorbent with high adsorptive selectivity for uremic toxins. We evaluated patient preference for and adherence to DW-7202 versus AST-120 therapy and compared treatment efficacy and safety in patients with pre-dialysis CKD.

Materials and methods: A seven-center, randomized, open-label, two-way crossover, active-controlled, phase IV clinical trial was conducted. Patients with stable CKD were randomly assigned to receive DW-7202 (capsule type) or AST-120 (granule type) for 12 weeks. The groups then switched to the other adsorbent and took it for the next 12 weeks. Patient preference was the primary outcome. Secondary outcomes included changes in estimated glomerular filtration rate (eGFR) and serum creatinine, cystatin C, and indoxyl sulfate (IS) levels.

Results: Significantly more patients preferred DW-7202 than AST-120 (p<0.001). Patient adherence improved after switching from AST-120 to DW-7202; there was no apparent change in adherence after switching from DW-7202 to AST-120. Changes in eGFR and serum creatinine, cystatin C, and IS levels were not significantly different according to adsorbent type. There was also no significant difference in the incidences of adverse events during treatment with DW-7202 and AST-120.

Conclusion: DW-7202 can be considered as an alternative to AST-120 in patients who cannot tolerate or show poor adherence to granule type adsorbents. Further studies to evaluate factors affecting patient preferences and improved adherence are warranted (Clinical trial registration No. NCT02681952).

Keywords: AST-120; Chronic kidney disease; DW-7202; adherence; preference.

Conflict of interest statement

The authors have no potential conflicts of interest to disclose.

© Copyright: Yonsei University College of Medicine 2021.

Figures

Fig. 1. Study design and subject disposition:…
Fig. 1. Study design and subject disposition: 153 patients were randomly assigned.
Fig. 2. Preferences of study subjects for…
Fig. 2. Preferences of study subjects for the types of oral adsorbent.
Fig. 3. Changes in variables of the…
Fig. 3. Changes in variables of the secondary efficacy. eGFR, estimated glomerular filtration rate; IS, indoxyl sulfate.
Fig. 4. Adherence of subjects according to…
Fig. 4. Adherence of subjects according to type of oral adsorbent.

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