RolE of AST120 in sarCOpenia preVEntion in pRe-dialYsis Chronic Kidney Disease Patients (RECOVERY): Prospective Open-label Randomized Controlled Multicenter Study

This study is to assess the effect of 48 weeks administration of Renamezin capsule on prevention of sarcopenia in pre-dialysis patients with chronic kidney disease.

Start Date23 Nov 2018

Sponsor / Collaborator-

NCT02681991 / CompletedPhase 4

Phase Ⅳ Clinical Trial to Evaluate of Renamezin in Patients With Chronic Renal Failure.

Renamezin Capsule (an oral adsorbent) lowers indoxyl sulfate levels in patient with chronic renal failure.
120 patients with chronic renal failure(baseline serum creatinine:1.5-5.0mg/dl).
Renamezin is administered 6.0mg/day. The treatment period is 2 months. The change in serum indoxyl sulfate will be evaluated.

Start Date01 Jan 2016

Sponsor / Collaborator

Daewon Pharmaceutical Co., Ltd.

NCT02681952 / CompletedPhase 4

A Multicenter, Randomized, Open-labeled, Cross-over, Active-controlled, Phase IV Clinical Trial to Evaluate the Preference of Formulation and the Efficacy and Safety of Renamezin and Kremezin in Pre-dialysis Patients With Chronic Renal Failure

Start Date01 Dec 2015

Sponsor / Collaborator

Daewon Pharmaceutical Co., Ltd.

100 Clinical Results associated with Spherical adsorptive carbon(Daewon Pharmaceutical Co., Ltd.)

100 Translational Medicine associated with Spherical adsorptive carbon(Daewon Pharmaceutical Co., Ltd.)

100 Patents (Medical) associated with Spherical adsorptive carbon(Daewon Pharmaceutical Co., Ltd.)

Literatures (Medical) associated with Spherical adsorptive carbon(Daewon Pharmaceutical Co., Ltd.)

10 Jul 2023·Kidney research and clinical practice

Factors associated with gait speed: results from the RolE of AST120 (Renamezin) in sarCOpenia preVEntion in pRe-dialYsis chronic kidney disease patients (RECOVERY) study.

Article

Author: Kim, Su Hyun ; Kang, Seock Hui ; Kim, Jun Chul ; Cha, Ran-Hui ; Han, Miyeun ; Song, Sang Heon ; An, Won Suk

BackgroundGait speed is an important measure of functional ability. This study aimed to investigate the factors associated with gait speed in patients with chronic kidney disease. The study focused on sarcopenic components, plasma uremic or inflammatory marker levels, and quality of life effects.MethodsThe RolE of AST120 (Renamezin) in sarCOpenia preVEntion in pRe-dialYsis chronic kidney disease patients is a 48-week, randomized controlled, parallel-group, open-label, multicenter trial to determine the role of Renamezin (Daewon Pharmaceutical Co., Ltd.) in patients with chronic kidney disease. The participants were classified into four groups according to gait speed: ≤0.8, 0.8-1.0, ≤1.0-1.3, and ≥1.3 m/sec. Linear regression analysis was performed to identify the factors associated with gait speed.ResultsThe group with a gait speed of ≤0.8 m/sec was the oldest and had the highest proportion of participants with low education level and medical aid. Participants with a gait speed of ≤0.8 m/sec showed the lowest physical and mental component scale scores. The interleukin-6 (IL-6) level tended to be the higher trend in the lowest gait speed group. In the multivariate linear regression analysis adjusted for age, sex, diabetes mellitus, and estimated glomerular filtration rate, insurance status, handgrip strength, IL-6 level, hemoglobin level, mental component scale score, and physical component scale score were significantly associated with gait speed.ConclusionIn conclusion, gait speed is associated with handgrip strength, IL-6 level, and various components of quality of life in predialysis chronic kidney disease patients.

01 Feb 2022·Journal of Cachexia, Sarcopenia and MuscleQ1 · MEDICINE

Effects of AST‐120 on muscle health and quality of life in chronic kidney disease patients: results of RECOVERY study

Q1 · MEDICINE

ArticleOA

Author: Kim, Su‐Hyun ; Han, Mi Yeun ; Kang, Seok Hui ; Cha, Ran‐hui ; Kim, Jun Chul ; An, Won Suk

AbstractBackgroundThe prevalence of sarcopenia is increased with declining renal function. Elevated serum indoxyl sulfate levels are associated with poor skeletal muscle conditions. We aimed to determine the effects of AST‐120, the oral adsorbent of indoxyl sulfate, on sarcopenia and sarcopenia‐associated factors in chronic kidney disease patients.MethodsThis was a 48 week, randomized controlled, parallel group, open‐label, multicentre trial (n = 150). The participants were randomly assigned in a 1:1 ratio to the control (CON) and AST‐120 (Renamezin®, REN) groups. Outcome measurements were performed at baseline and every 24 weeks for 48 weeks. The primary outcome was gait speed difference ≥0.1 m/s between the two groups, and secondary outcomes included hand grip strength, muscle mass, and health‐related quality of life.ResultsA difference of gait speed ≥0.1 m/s was not observed during the study period. The mean dynamic‐start gait speed in the REN group increased from baseline to 48 weeks (1.04 ± 0.31 to 1.08 ± 0.32 m/s, P = 0.019). The static‐start gait speed changed by −0.024 and 0.04 m/s (P = 0.049) in the CON and REN groups over 48 weeks, respectively. Hand grip strength decreased during the first 24 weeks and did not significantly change over the next 24 weeks in either group. The proportion of low muscle mass or sarcopenia at baseline was larger in the REN group than in the CON group, but the difference attenuated over the study period [low muscle mass and sarcopenia in the CON and REN groups at baseline, 4.0% vs. 18.9% (P = 0.004) and 2.7% vs. 13.5% (P = 0.017); at 24 weeks, 2.9% vs. 13.6% (P = 0.021) and 1.4% vs. 10.5% (P = 0.029); and at 48 weeks, 7.6% vs. 12.9% (P = 0.319) and 4.5% vs. 8.1% (P = 0.482), respectively]. Bodily pain, vitality, symptoms/problems, and cognitive function in the REN group improved, while the quality of social interactions and the kidney disease effects in the CON group aggravated from baseline to 48 weeks. Interaction between time and group was evident only in symptoms/problems, cognitive function, and kidney disease effects.ConclusionsThe addition of AST‐120 to standard treatment in chronic kidney disease patients did not make a significant difference in gait speed, although AST‐120 modestly had beneficial effects on gait speed change and quality of life and showed the potential to improve sarcopenia. (clinicaltrials.gov: NCT03788252).

PLOS ONEQ3 · CROSS-FIELD

Effect of Renamezin upon attenuation of renal function decline in pre-dialysis chronic kidney disease patients: 24-week prospective observational cohort study

Q3 · CROSS-FIELD

ArticleOA

Author: Lee, So-Young ; Jo, Sang Kyung ; Cho, AJin ; Chang, Yoon Kyung ; Han, Kum Hyun ; Oh, Dong-Jin ; Lee, Eun Young ; Park, Hayne Cho ; Lee, Young-Ki ; Kim, Do Hyoung ; Kim, Juhee ; Yun, Kyu-Sang

Renamezin® is a modified capsule-type oral spherical adsorptive carbon which lowers indoxyl sulfate levels in patients with advanced chronic kidney disease (CKD). This 24-week prospective observational cohort study was performed to evaluate the effect of Renamezin® upon attenuation of renal function decline. A total of 1,149 adult patients with baseline serum creatinine 2.0–5.0 mg/dL were enrolled from 22 tertiary hospital in Korea from April 2016 to September 2018. Among them, a total of 686 patients completed the study and were included in the intention-to-treat analysis. A total of 1,061 patients were included in the safety analysis. The mean age was 63.5 years and male patients were predominant (63.6%). Most of the patients (76.8%) demonstrated high compliance with study drug (6g per day). After 24 week of treatment, serum creatinine was increased from 2.86±0.72 mg/dL to 3.06±1.15 mg/dL (p<0.001), but estimated glomerular filtration rate was not changed significantly during observation period (22.3±6.8 mL/min/1.73m2 to 22.1±9.1 mL/min/1.73m2, p = 0.243). Patients with age over 65 years old and those under good systolic blood pressure control <130 mmHg were most likely to get benefit from Renamezin® treatment to preserve renal function. A total of 98 (9.2%) patients out of 1,061 safety population experienced 134 adverse events, of which gastrointestinal disorders were the most common. There were no serious treatment-related adverse events. Renamezin® can be used safely to attenuate renal function decline in moderately advanced CKD patients.

100 Deals associated with Spherical adsorptive carbon(Daewon Pharmaceutical Co., Ltd.)

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Indication	Country/Location	Organization	Date
Chronic Kidney Diseases	KR	Daewon Pharmaceutical Co., Ltd.	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Renamezin (ASN2016)	Not Applicable	Chronic Kidney Diseases serum indoxyl sulfate levels	35	Renamezin	tazrmgzyjc(smokdvquym) = vomiting and diarrhea in 4 patients (11.6%) pdzxqicraq (juqnqltvys ) View more	Positive	15 Nov 2016

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