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

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 th...

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Autores principales: Kee, Youn Kyung, Han, Sang Youb, Kang, Duk-Hee, Noh, Jung Woo, Jeong, Kyung Hwan, Kim, Gheun-Ho, Kim, Yang Wook, Kim, Beom Seok
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Yonsei University College of Medicine 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7820454/
https://www.ncbi.nlm.nih.gov/pubmed/33381933
http://dx.doi.org/10.3349/ymj.2021.62.1.41
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author Kee, Youn Kyung
Han, Sang Youb
Kang, Duk-Hee
Noh, Jung Woo
Jeong, Kyung Hwan
Kim, Gheun-Ho
Kim, Yang Wook
Kim, Beom Seok
author_facet Kee, Youn Kyung
Han, Sang Youb
Kang, Duk-Hee
Noh, Jung Woo
Jeong, Kyung Hwan
Kim, Gheun-Ho
Kim, Yang Wook
Kim, Beom Seok
author_sort Kee, Youn Kyung
collection PubMed
description 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).
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spelling pubmed-78204542021-01-27 Comparison of Different Types of Oral Adsorbent Therapy in Patients with Chronic Kidney Disease: A Multicenter, Randomized, Phase IV Clinical Trial Kee, Youn Kyung Han, Sang Youb Kang, Duk-Hee Noh, Jung Woo Jeong, Kyung Hwan Kim, Gheun-Ho Kim, Yang Wook Kim, Beom Seok Yonsei Med J Original Article 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). Yonsei University College of Medicine 2021-01-01 2020-12-23 /pmc/articles/PMC7820454/ /pubmed/33381933 http://dx.doi.org/10.3349/ymj.2021.62.1.41 Text en © Copyright: Yonsei University College of Medicine 2021 https://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Kee, Youn Kyung
Han, Sang Youb
Kang, Duk-Hee
Noh, Jung Woo
Jeong, Kyung Hwan
Kim, Gheun-Ho
Kim, Yang Wook
Kim, Beom Seok
Comparison of Different Types of Oral Adsorbent Therapy in Patients with Chronic Kidney Disease: A Multicenter, Randomized, Phase IV Clinical Trial
title Comparison of Different Types of Oral Adsorbent Therapy in Patients with Chronic Kidney Disease: A Multicenter, Randomized, Phase IV Clinical Trial
title_full Comparison of Different Types of Oral Adsorbent Therapy in Patients with Chronic Kidney Disease: A Multicenter, Randomized, Phase IV Clinical Trial
title_fullStr Comparison of Different Types of Oral Adsorbent Therapy in Patients with Chronic Kidney Disease: A Multicenter, Randomized, Phase IV Clinical Trial
title_full_unstemmed Comparison of Different Types of Oral Adsorbent Therapy in Patients with Chronic Kidney Disease: A Multicenter, Randomized, Phase IV Clinical Trial
title_short Comparison of Different Types of Oral Adsorbent Therapy in Patients with Chronic Kidney Disease: A Multicenter, Randomized, Phase IV Clinical Trial
title_sort comparison of different types of oral adsorbent therapy in patients with chronic kidney disease: a multicenter, randomized, phase iv clinical trial
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7820454/
https://www.ncbi.nlm.nih.gov/pubmed/33381933
http://dx.doi.org/10.3349/ymj.2021.62.1.41
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