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

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.

SUBMITTER: Park HC

PROVIDER: S-EPMC8183994 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundIn patients with chronic kidney disease (CKD) hyperuricemia is common. Evidence that hyperuricemia might also play a causal role in vascular disease, hypertension and progression of CKD is accumulating. Therefore, we studied the association between baseline uric acid (UA) levels and the rate of decline in renal function and time until start of dialysis in pre-dialysis patients.MethodsData from the PREPARE-2 study were used. The PREPARE-2 study is an observational prospective cohort study including incident pre-dialysis patients with CKD stages IV-V in the years between 2004 and 2011. Patients were followed for a median of 14.9 months until start of dialysis, kidney transplantation, death, or censoring. Main outcomes were the change in the rate of decline in renal function (measured as estimated glomerular filtration rate (eGFR)) estimated using linear mixed models, and time until start of dialysis estimated using Cox proportional hazards models.ResultsIn this analysis 131 patients were included with a baseline UA level (mean (standard deviation (SD)) of 8.0 (1.79) mg/dl) and a mean decline in renal function of -1.61 (95% confidence interval (CI), -2.01; -1.22) ml/min/1.73 m2/year. The change in decline in GFR associated with a unit increase in UA at baseline was -0.14 (95% CI -0.61;0.33, p=0.55) ml/min/1.73 m2/year. Adjusted for demography, comorbidities, diet, body mass index (BMI), blood pressure, lipids, proteinuria, diuretic and/or allopurinol usage the change in decline in eGFR did not change. The hazard ratio (HR) for starting dialysis for each mg/dl increase in UA at baseline was 1.08 (95% CI, 0.94;1.24, p=0.27). After adjustment for the same confounders the HR became significant at 1.26 (95% CI, 1.06;1.49, p=0.01), indicating an earlier start of dialysis with higher levels of UA.ConclusionAlthough high UA levels are not associated with an accelerated decline in renal function, a high serum UA level in incident pre-dialysis patient is a risk factor for an earlier start of dialysis.

Project description:♦ BACKGROUND: The aim of the study was to assess risk factors for residual renal function (RRF) decline in children during the first/second year of chronic peritoneal dialysis (PD). ♦ METHODS: The study group included 56 children with end-stage renal disease (ESRD) (age 10.13 ± 4.86 years), including 18 on continuous ambulatory PD (CAPD) and 38 on automated PD (APD), in whom we evaluated RRF (daily diuresis [mL/m2/24 h], residual glomerular filtration rate (rGFR) [mL/min/1.73 m2]), etiology of ESRD, PD fluid volume (mL/m2/24 h), glucose load (g/m2/24 h), ultrafiltration (mL/m2/24 h), peritoneal permeability (D/PCrea 4h, D/D0 Glu 4h), dialysis adequacy (twKt/V, twCCr [L/week/1.73 m2]), blood pressure (BP), biochemical parameters, and medications used. Duration of follow-up was 24 months. ♦ RESULTS: Mean diuresis before initiation of PD was 1,394.93 ± 698.37 (mL/m2/24 h), and mean rGFR was 7.41 ± 3.96 (mL/min/1.73 m2). The rate of daily diuresis decline was -529.34 ± 546.28 in the first year and -107.10 ± 291.54 (mL/m2/24 h) in the second year (p = 0.005), and the rate of rGFR decline was -3.35 ± 3.73 in the first year and -1.63 ± 1.85 (mL/min/1.73 m2) in the second year (p = 0.118). Eleven (19.64%) patients became anuric. In univariate analysis, the rate of daily diuresis decline in the first year was related to baseline diuresis (r = -0.29, p = 0.031), proteinuria (r = -0.43, p = 0.001), and systolic BP (r = -0.31, p = 0.020); 12-month changes (Δ0 - 12) in PD fluid volume (r = -0.37, p = 0.004), glucose load (r = -0.28, p = 0.035), and ultrafiltration (r = -0.38, p = 0.004); serum calcium-phosphorus product (r = -0.41, p = 0.002); and Δ0 - 12 body mass index (BMI) Z-score (r = 0.30, p = 0.024); while the rate of rGFR decline in the first year was related only to baseline rGFR (r = -0.57, p < 0.001). In multivariate analysis, significant predictors of the rate of daily diuresis decline in the first year were baseline diuresis (β = -0.386, p < 0.001) and proteinuria (β = -0.278, p = 0.017), mean systolic BP Z-score (β = -0.237, p = 0.027), and age at the onset of PD (β = -0.224, p = 0.037), while predictors of the rate of rGFR decline were baseline rGFR (β = -0.607, p < 0.001) and baseline proteinuria (β = -0.225, p = 0.046). In the second year, the only predictors of the rate of rGFR decline were D/D0 Glu 4h (r = 0.44, p = 0.033, univariate analysis) and rGFR at 12 months (β = -0.499, p = 0.044). ♦ CONCLUSION: The most important risk factors for rapid RRF decline in children during the first year of chronic PD include higher baseline daily diuresis and proteinuria, and additional factors are systolic BP and age at the onset of PD; while high baseline GFR and low peritoneal transport status may be the only important factors during the second year.

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

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