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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

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease AST-120 Drug: AST-120 Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: AST-120 group
Administration of AST-120
Drug: AST-120
No Intervention: 2

Primary Outcome Measures :
  1. renal function change [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. anemia [ Time Frame: 1 year ]

Other Outcome Measures:
  1. lipid profile and uric acid [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01681303

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Department of Nephrology, Chang Gung Memorial Hospital
Keelung, Taiwan, 204
Sponsors and Collaborators
Chang Gung Memorial Hospital
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Principal Investigator: I-Wen Wu, MD Chang Gung Memorial Hospital
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Responsible Party: iwenwu, Attending Physician, Chang Gung Memorial Hospital Identifier: NCT01681303    
Other Study ID Numbers: IWW-0004
98-794A3 ( Other Grant/Funding Number: Conmed )
First Posted: September 7, 2012    Key Record Dates
Last Update Posted: August 6, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency