Effect of An Oral Absorbent AST-120 in Late-stage Chronic Kidney Disease (CKD) Patients.
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
- renal function change [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- anemia [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- lipid profile and uric acid [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2009|
|Study Completion Date:||December 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Experimental: AST-120 group
Administration of AST-120
|No Intervention: 2|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01681303
|Department of Nephrology, Chang Gung Memorial Hospital|
|Keelung, Taiwan, 204|
|Principal Investigator:||I-Wen Wu, MD||Chang Gung Memorial Hospital|