Predictive factors for efficacy of AST-120 treatment in diabetic nephropathy

A prospective single-arm, open-label, multi-center study

You Cheol Hwang, Se Won Kim, Kyu Yeon Hur, Bong Soo Cha, In Joo Kim, Tae Sun Park, Sei-Hyun Baik, Kun Ho Yoon, Kwan Woo Lee, In Kyu Lee, Moon Kyu Lee

Research output: Contribution to journalArticle

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Abstract

Background: Removal of uremic toxins such as indoxyl sulfate by AST-120 is known to improve renal function and delay the initiation of dialysis in patients with advanced chronic kidney disease. However, it is unclear whether the addition of AST-120 to conventional treatments is effective in delaying the progression of renal dysfunction in patients with diabetic nephropathy. Methods: A total of 100 patients with type 2 diabetes and renal dysfunction (serum creatinine levels ranging from 1.5 to 3.0 mg/dL) were recruited from eight centers in Korea and treated with AST-120 (6 g/day) for 24 weeks. The primary endpoint was improvement in renal function measured as the gradient of the reciprocal serum creatinine level (1/sCr) over time (i.e., the ratio of 1/sCr time slope for post- to pre-AST-120 therapy). A response was defined as a ratio change of the regression coefficient of 1/sCr ≤ 0.90. Results: Renal function improved in 80.3% of patients (61/76) after 24 weeks of AST-120 treatment. There were no differences between responder and non-responder groups in baseline characteristics except for diastolic blood pressure (73.5 ± 9.5 mmHg in the responder group vs. 79.3 ± 11.1 mmHg in the non-responder group; P = 0.046). Serum lipid peroxidation level decreased significantly in the responder group (from 2.25 ± 0.56 μmol/L to 1.91 ± 0.72 μmol/L; P = 0.002) but not in the non-responder group. Conclusion: The addition of AST-120 to conventional treatments may delay the progression of renal dysfunction in diabetic nephropathy. The antioxidant effect of AST-120 might contribute to improvement in renal function.

Original languageEnglish
Article numbere117
JournalJournal of Korean medical science
Volume34
Issue number15
DOIs
Publication statusPublished - 2019 Apr 22

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Diabetic Nephropathies
Kidney
Therapeutics
Creatinine
Indican
Serum
Blood Pressure
Korea
AST 120
Chronic Renal Insufficiency
Type 2 Diabetes Mellitus
Lipid Peroxidation
Dialysis
Antioxidants

Keywords

  • Antioxidants
  • Creatinine
  • Diabetic Nephropathy
  • Indoxyl Sulfate
  • Oxidative Stress

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Predictive factors for efficacy of AST-120 treatment in diabetic nephropathy : A prospective single-arm, open-label, multi-center study. / Hwang, You Cheol; Kim, Se Won; Hur, Kyu Yeon; Cha, Bong Soo; Kim, In Joo; Park, Tae Sun; Baik, Sei-Hyun; Yoon, Kun Ho; Lee, Kwan Woo; Lee, In Kyu; Lee, Moon Kyu.

In: Journal of Korean medical science, Vol. 34, No. 15, e117, 22.04.2019.

Research output: Contribution to journalArticle

Hwang, You Cheol ; Kim, Se Won ; Hur, Kyu Yeon ; Cha, Bong Soo ; Kim, In Joo ; Park, Tae Sun ; Baik, Sei-Hyun ; Yoon, Kun Ho ; Lee, Kwan Woo ; Lee, In Kyu ; Lee, Moon Kyu. / Predictive factors for efficacy of AST-120 treatment in diabetic nephropathy : A prospective single-arm, open-label, multi-center study. In: Journal of Korean medical science. 2019 ; Vol. 34, No. 15.
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abstract = "Background: Removal of uremic toxins such as indoxyl sulfate by AST-120 is known to improve renal function and delay the initiation of dialysis in patients with advanced chronic kidney disease. However, it is unclear whether the addition of AST-120 to conventional treatments is effective in delaying the progression of renal dysfunction in patients with diabetic nephropathy. Methods: A total of 100 patients with type 2 diabetes and renal dysfunction (serum creatinine levels ranging from 1.5 to 3.0 mg/dL) were recruited from eight centers in Korea and treated with AST-120 (6 g/day) for 24 weeks. The primary endpoint was improvement in renal function measured as the gradient of the reciprocal serum creatinine level (1/sCr) over time (i.e., the ratio of 1/sCr time slope for post- to pre-AST-120 therapy). A response was defined as a ratio change of the regression coefficient of 1/sCr ≤ 0.90. Results: Renal function improved in 80.3{\%} of patients (61/76) after 24 weeks of AST-120 treatment. There were no differences between responder and non-responder groups in baseline characteristics except for diastolic blood pressure (73.5 ± 9.5 mmHg in the responder group vs. 79.3 ± 11.1 mmHg in the non-responder group; P = 0.046). Serum lipid peroxidation level decreased significantly in the responder group (from 2.25 ± 0.56 μmol/L to 1.91 ± 0.72 μmol/L; P = 0.002) but not in the non-responder group. Conclusion: The addition of AST-120 to conventional treatments may delay the progression of renal dysfunction in diabetic nephropathy. The antioxidant effect of AST-120 might contribute to improvement in renal function.",
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author = "Hwang, {You Cheol} and Kim, {Se Won} and Hur, {Kyu Yeon} and Cha, {Bong Soo} and Kim, {In Joo} and Park, {Tae Sun} and Sei-Hyun Baik and Yoon, {Kun Ho} and Lee, {Kwan Woo} and Lee, {In Kyu} and Lee, {Moon Kyu}",
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T1 - Predictive factors for efficacy of AST-120 treatment in diabetic nephropathy

T2 - A prospective single-arm, open-label, multi-center study

AU - Hwang, You Cheol

AU - Kim, Se Won

AU - Hur, Kyu Yeon

AU - Cha, Bong Soo

AU - Kim, In Joo

AU - Park, Tae Sun

AU - Baik, Sei-Hyun

AU - Yoon, Kun Ho

AU - Lee, Kwan Woo

AU - Lee, In Kyu

AU - Lee, Moon Kyu

PY - 2019/4/22

Y1 - 2019/4/22

N2 - Background: Removal of uremic toxins such as indoxyl sulfate by AST-120 is known to improve renal function and delay the initiation of dialysis in patients with advanced chronic kidney disease. However, it is unclear whether the addition of AST-120 to conventional treatments is effective in delaying the progression of renal dysfunction in patients with diabetic nephropathy. Methods: A total of 100 patients with type 2 diabetes and renal dysfunction (serum creatinine levels ranging from 1.5 to 3.0 mg/dL) were recruited from eight centers in Korea and treated with AST-120 (6 g/day) for 24 weeks. The primary endpoint was improvement in renal function measured as the gradient of the reciprocal serum creatinine level (1/sCr) over time (i.e., the ratio of 1/sCr time slope for post- to pre-AST-120 therapy). A response was defined as a ratio change of the regression coefficient of 1/sCr ≤ 0.90. Results: Renal function improved in 80.3% of patients (61/76) after 24 weeks of AST-120 treatment. There were no differences between responder and non-responder groups in baseline characteristics except for diastolic blood pressure (73.5 ± 9.5 mmHg in the responder group vs. 79.3 ± 11.1 mmHg in the non-responder group; P = 0.046). Serum lipid peroxidation level decreased significantly in the responder group (from 2.25 ± 0.56 μmol/L to 1.91 ± 0.72 μmol/L; P = 0.002) but not in the non-responder group. Conclusion: The addition of AST-120 to conventional treatments may delay the progression of renal dysfunction in diabetic nephropathy. The antioxidant effect of AST-120 might contribute to improvement in renal function.

AB - Background: Removal of uremic toxins such as indoxyl sulfate by AST-120 is known to improve renal function and delay the initiation of dialysis in patients with advanced chronic kidney disease. However, it is unclear whether the addition of AST-120 to conventional treatments is effective in delaying the progression of renal dysfunction in patients with diabetic nephropathy. Methods: A total of 100 patients with type 2 diabetes and renal dysfunction (serum creatinine levels ranging from 1.5 to 3.0 mg/dL) were recruited from eight centers in Korea and treated with AST-120 (6 g/day) for 24 weeks. The primary endpoint was improvement in renal function measured as the gradient of the reciprocal serum creatinine level (1/sCr) over time (i.e., the ratio of 1/sCr time slope for post- to pre-AST-120 therapy). A response was defined as a ratio change of the regression coefficient of 1/sCr ≤ 0.90. Results: Renal function improved in 80.3% of patients (61/76) after 24 weeks of AST-120 treatment. There were no differences between responder and non-responder groups in baseline characteristics except for diastolic blood pressure (73.5 ± 9.5 mmHg in the responder group vs. 79.3 ± 11.1 mmHg in the non-responder group; P = 0.046). Serum lipid peroxidation level decreased significantly in the responder group (from 2.25 ± 0.56 μmol/L to 1.91 ± 0.72 μmol/L; P = 0.002) but not in the non-responder group. Conclusion: The addition of AST-120 to conventional treatments may delay the progression of renal dysfunction in diabetic nephropathy. The antioxidant effect of AST-120 might contribute to improvement in renal function.

KW - Antioxidants

KW - Creatinine

KW - Diabetic Nephropathy

KW - Indoxyl Sulfate

KW - Oxidative Stress

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