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

NCT01458652 | Completed Phase 4 DMC

• 1 other identifier: 1000121
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Loss of Solute Clearance

Keywords

AST-120; HDF; Replacement Volume described above

Outcome Measures

Primary Outcomes (1)

• Efficacy of AST-120 on removal of plasma protein-bound uremic toxins e.g.p-cresol and indoxyl sulfate.

  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.

  three months

Secondary Outcomes (1)

• Effects of replacement volume and AST-120 on markers of inflammation and oxidative stress

  three months

Study Arms (1)

Lifestyle counseling

EXPERIMENTAL

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

Drug: Kremezin

Interventions

Kremezin DRUG

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

Also known as: AST-120

Lifestyle counseling

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Thrice a week for more then
• Receiving HDF patients who had been treated for \> 3 months
• Non-smoking
• Informed Consent
• No significant change of medication

You may not qualify if:

• Malignancy
• Active infection
• Congestive heart failure (CHF)
• History of Gastrointestinal Disease(Active peptic ulcer, severe constipation or severe GI dysmotility)

Sponsors & Collaborators

• Tungs' Taichung Metroharbour Hospital: lead

Study Sites (1)

PS Lim

Taichung, 435, Taiwan

Location

MeSH Terms

Interventions

AST 120

Study Officials

• Lim Paik-Seong

  Lim Paik Seong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 2, 2011
• First Posted: October 25, 2011
• Study Start: January 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: May 9, 2014

Record last verified: 2014-05

Locations

TW (1)