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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Paik Seong Lim, Tungs' Taichung Metroharbour Hospital
ClinicalTrials.gov Identifier:
NCT01458652
First received: May 2, 2011
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

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: Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


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

Drug:Kremezin

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

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  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01458652

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

No publications provided

Responsible Party: Paik Seong Lim, Director, Tungs' Taichung Metroharbour Hospital
ClinicalTrials.gov Identifier: NCT01458652     History of Changes
Other Study ID Numbers: 1000121
Study First Received: May 2, 2011
Last Updated: April 17, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by Tungs’ Taichung Metroharbour Hospital:
AST-120
HDF
Replacement Volume described above

ClinicalTrials.gov processed this record on April 20, 2014