Abstract
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.
Highlights
Chronic kidney disease (CKD) is the state of chronic functional or structural failure of kidneys which results in the decline of renal function [1]
The metabolic wastes from dietary protein such as indoxyl sulfate or p-cresyl sulfate are known to act as uremic toxin which accelerate CKD progression [2]
This is the first study to evaluate the effect of novel drug Renamezin1 for attenuation of renal function decline in moderately advanced CKD patients
Summary
Chronic kidney disease (CKD) is the state of chronic functional or structural failure of kidneys which results in the decline of renal function [1]. Various small uremic toxins cannot be effectively excreted through urine. The metabolic wastes from dietary protein such as indoxyl sulfate or p-cresyl sulfate are known to act as uremic toxin which accelerate CKD progression [2]. The AST-120 (Kremezin, Kureha Corporation, Tokyo, Japan), an oral granule-type spherical carbon adsorbent, was developed to delay CKD progression by adsorbing uremic toxins and their precursors and excreting them into feces. Previous observational studies and animal studies demonstrated that treatment with AST-120 reduces the level of indoxyl sulfate [3,4], attenuates renal function decline [5,6] and renal sclerosis [7,8]
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