We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT01458652
Recruitment Status : Completed
First Posted : October 25, 2011
Last Update Posted : May 9, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Loss of Solute Clearance Drug: Kremezin Phase 4

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: Single (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
Study Start Date : January 2011
Primary Completion Date : October 2013
Study Completion Date : October 2013
Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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 ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT01458652     History of Changes
Other Study ID Numbers: 1000121
First Posted: October 25, 2011    Key Record Dates
Last Update Posted: May 9, 2014
Last Verified: May 2014

Keywords provided by Paik Seong Lim, Tungs' Taichung Metroharbour Hospital:
Replacement Volume described above