Chronic Kidney Disease Clinical Trial
Recent research work has directed especial attention toward a distinct group of uremic
retension molecules, called "protein-bound uremic toxins". The prototypes of this group of
uremic toxins are indoxyl sulfate and p-cresol. These uremic toxins can promote production
of free radical and impair antioxidant system and exerts direct toxicity on different cells
and organs, including mesangial, tubular, endothelial cell and osteoblasts. Accumulation of
these protein bound uremic toxins results in glomerular sclerosis and interstitial fibrosis
of kidneys of uremic rats and confer skeletal resistance to parthyroid hormone in uremic
patients. In hemodialysis, high serum p-cresol level is associated with higher
cardiovascular mortality.
AST-120 (Kremezin) is a carbonated oral absorbent extensively used in Japan and Korea. It
has superior adsorption ability for certain small-molecular weight organic compounds known
to accumulate in patients with CKD. In uremic rats and CKD patients, oral administration of
AST-120 decreased the elevated pretreatment levels of serum indoxyl sulfate. In Japan, it
was reported that AST-120 suppressed the increase in serum creatinine levels, prevented
proteinuria, improved uremic symptoms, and, consequently, led to the postponement of
dialysis therapy.
Value of AST-120 on the outcome of late-stage CKD patients is still unknown. We hypothesized
AST-120 through reduction of level of indoxyl sulfate and p-cresol can improved the
morbidity- mortality of CKD patients.
The principal aim of this prospective cohort study is to investigate the effectiveness of
AST-120 in incidence of dialysis and mortality of late-stage CKD patients. Determination of
this relationship can help to establish new therapeutic strategy in the treatment of
late-stage CKD patients.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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