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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
iwenwu, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01681303
First received: September 5, 2012
Last updated: August 3, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Chronic Kidney Disease
AST-120
Drug: AST-120
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • renal function change [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • anemia [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • lipid profile and uric acid [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 51
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AST-120 group
Administration of AST-120
Drug: AST-120
No Intervention: 2

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681303

Locations
Taiwan
Department of Nephrology, Chang Gung Memorial Hospital
Keelung, Taiwan, 204
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: I-Wen Wu, MD Chang Gung Memorial Hospital
  More Information

No publications provided

Responsible Party: iwenwu, Attending Physician, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01681303     History of Changes
Other Study ID Numbers: IWW-0004, 98-794A3
Study First Received: September 5, 2012
Last Updated: August 3, 2013
Health Authority: Taiwan: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on October 20, 2014