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Effect of Replacement Volume of Haemodiafiltration and AST-120 on Toxins, Oxidative Stress and MicroInflammation

This study has been completed.
Information provided by (Responsible Party):
Paik Seong Lim, Tungs' Taichung Metroharbour Hospital Identifier:
First received: May 2, 2011
Last updated: May 8, 2014
Last verified: May 2014
Accumulating evidence suggested that increased oxidative stress (OxSt) as well as inflammation are risk factors for cardiovascular events in hemodialysis patients. The incremental effect of online haemodiafiltration (OL-HDF) on markers of microinflammation ,and OxSt is less clear. Besides, the relationship between protein-bind uremic toxin and microinflammation remains obscure. The aim of this study was to evaluate the effect volume replacement of on-line hemodiafiltration on proinflammatory peripheral monocytes (percentage of CD14+CD16+ cells), PAF, IL-6 and on the plasma level of several oxidative stress markers as well as several protein-bound uremic toxins such as p-cresol, indole sulfate etc. In a case controlled study, 30 patients on OL-HDF will be evaluated. The association between protein-bound uremic toxins such as p-cresol, indole sulfate etc and AST-120, a spherical adsorptive carbon preparation (Kremezin) will also being investigated.

Condition Intervention Phase
Loss of Solute Clearance
Drug: Kremezin
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effect of Replacement Volume and AST-120 (Kremezin) on Protein-bound Toxins, Oxidative Stress and MicroInflammation in Patients Receiving Online Hemodiafiltration

Further study details as provided by Tungs’ Taichung Metroharbour Hospital:

Primary Outcome Measures:
  • Efficacy of AST-120 on removal of plasma protein-bound uremic toxins e.g.p-cresol and indoxyl sulfate. [ Time Frame: three months ]
    Assess the effect of administration of AST-120 on the clearance of large molecular weight protein-bound uremic toxins. Changes in serum levels of p-cresol and indoxyl sulfate ( Units in mg/L)from baseline after 3 months of AST-120 will be measured.

Secondary Outcome Measures:
  • Effects of replacement volume and AST-120 on markers of inflammation and oxidative stress [ Time Frame: three months ]
    To evaluate if the above intervention can affect biomarkers of inflammation (hsCRP, IL_6 and PAF) and oxidative stress(such as AGEs, AOPPS etc) of these dialysis patients. Changes in serum levels of these biomarkers after 3 months of AST-120 adminstration will be evaluated

Enrollment: 30
Study Start Date: January 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle counseling


Other Names:AST-120

Kremezin is an oral adsorbent, 9g/day in treatment arm

Drug: Kremezin
Kremezin is an oral adsorbent, 9g/day in treatment arm
Other Name: AST-120

  Show Detailed Description


Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Thrice a week for more then

  1. Receiving HDF patients who had been treated for > 3 months
  2. Non-smoking
  3. Informed Consent
  4. No significant change of medication

Exclusion Criteria:

  1. Malignancy
  2. Active infection
  3. Congestive heart failure (CHF)
  4. History of Gastrointestinal Disease(Active peptic ulcer, severe constipation or severe GI dysmotility)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01458652

PS Lim
Taichung, Taiwan, 435
Sponsors and Collaborators
Tungs’ Taichung Metroharbour Hospital
Principal Investigator: Lim Paik-Seong Lim Paik Seong
  More Information

Responsible Party: Paik Seong Lim, Director, Tungs' Taichung Metroharbour Hospital Identifier: NCT01458652     History of Changes
Other Study ID Numbers: 1000121
Study First Received: May 2, 2011
Last Updated: May 8, 2014

Keywords provided by Tungs’ Taichung Metroharbour Hospital:
Replacement Volume described above processed this record on April 28, 2017