Effect of An Oral Absorbent AST-120 in Late-stage Chronic Kidney Disease (CKD) Patients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01681303
Recruitment Status : Completed
First Posted : September 7, 2012
Last Update Posted : August 6, 2013
Information provided by (Responsible Party):
iwenwu, Chang Gung Memorial Hospital

September 5, 2012
September 7, 2012
August 6, 2013
January 2009
September 2011   (Final data collection date for primary outcome measure)
renal function change [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT01681303 on Archive Site
anemia [ Time Frame: 1 year ]
Same as current
lipid profile and uric acid [ Time Frame: 1 year ]
Same as current
Effect of An Oral Absorbent AST-120 in Late-stage Chronic Kidney Disease (CKD) Patients.
Not Provided

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.

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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Chronic Kidney Disease
  • AST-120
Drug: AST-120
  • Experimental: AST-120 group
    Administration of AST-120
    Intervention: Drug: AST-120
  • No Intervention: 2
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2011
September 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • adults aged > 18 year-old or < 85 year-old
  • eGFR or CCR < 60 ml/min
  • hemoglobin < 10 g/dL, ESA-naïve, had adequate iron storage (serum ferritin > 200 ng/dL and transferrin saturation > 20%)
  • no spontaneous renal improvement or progression in past 3 months.

Exclusion Criteria:

  • renal transplant recipients, liver cirrhosis, bone marrow disorder
  • blood pressure > 170/80 mmHg in 3 occasions
  • recent cardiovascular disease (Coronary artery disease, myocardial ischemia, cerebrovascular disease or peripheral artery disease) or gastrointestinal bleeding in past 3 months
  • acute tubular necrosis in the past 3 months
  • unwilling to participate in the trial
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
98-794A3 ( Other Grant/Funding Number: Conmed )
Not Provided
Not Provided
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iwenwu, Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
Not Provided
Principal Investigator: I-Wen Wu, MD Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP