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

PLoS One. 2021 Jun 7;16(6):e0252186. doi: 10.1371/journal.pone.0252186. eCollection 2021.

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.

Publication types

  • Multicenter Study
  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Carbon / administration & dosage*
  • Creatinine / blood
  • Dialysis / methods
  • Disease Progression
  • Female
  • Glomerular Filtration Rate / drug effects
  • Humans
  • Kidney / diagnostic imaging*
  • Male
  • Middle Aged
  • Prospective Studies
  • Renal Dialysis / methods
  • Renal Insufficiency, Chronic / blood
  • Renal Insufficiency, Chronic / drug therapy*
  • Republic of Korea
  • Risk Factors

Substances

  • Carbon
  • Creatinine

Grants and funding

This study was sponsored by Daewon Pharmaceutical Company which provided grant funding and study drugs. However, the funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.