NCT00247507

Brief Summary

The aim of this study is to explore and identify the effects of acetylcysteine, a common mucolytic with anti-oxidant property, on alleviating the damage caused by increased oxidative stress in hemodialysis patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2005

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

October 18, 2006

Status Verified

October 1, 2005

First QC Date

October 31, 2005

Last Update Submit

October 17, 2006

Conditions

AnemiaAtherosclerosisEnd-Stage Renal DiseaseOxidative StressPro-Inflammation

Keywords

AnemiaatherosclerosisEnd-stage renal diseaseErythropoietinHemodialysisOxidative stressPro-inflammation

Outcome Measures

Primary Outcomes (3)

  • the changes of plasma ox-LDL levels

  • the changes of anemia status

  • the responsiveness to EPO therapy and severity of atherosclerosis

Interventions

acetylcysteineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • On HD thrice a week at our HD unit for more than three months
  • Informed consent
  • The dose of EPO and iron supplement is stationary in the previous one month
  • No taking acetylcysteine in previous one month
  • No using vitamin E-bonded dialysis membrane

You may not qualify if:

  • Severe liver disease (AST or ALT \>40 IU/L), proven malignancy, and severe cardiovascular disease (proved by cardiac catheter or echography examination)
  • Active infection or hospitalization in previous one month
  • Clinically significant bleeding episode in previous one month
  • Taking vitamin C, vitamin E or other known antioxidants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

Pan-Chiao, Taipei, 220, Taiwan

Location

MeSH Terms

Conditions

AnemiaAtherosclerosisKidney Failure, Chronic

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Shih-Ping Hsu, M.D.

    Far Eastern Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 31, 2005

First Posted

November 2, 2005

Study Start

September 1, 2005

Study Completion

December 1, 2005

Last Updated

October 18, 2006

Record last verified: 2005-10

Locations

TW(1)