This trial is active, not recruiting.

Conditions anemia, atherosclerosis, end-stage renal disease, oxidative stress, pro-inflammation
Treatment acetylcysteine
Phase phase 4
Sponsor Far Eastern Memorial Hospital
Start date September 2005
End date December 2005
Trial identifier NCT00247507, 94029


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

the changes of plasma ox-LDL levels
time frame:
the changes of anemia status
time frame:
the responsiveness to EPO therapy and severity of atherosclerosis
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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.

Additional Information

Principal investigator Shih-Ping Hsu, M.D.
Description Oxidative stress in patients with renal failure is higher than in healthy controls. Once undergoing hemodialysis (HD) therapy, patients with end-stage renal disease even have more oxidative stress. Reactive oxygen species (ROS) denature the vital molecules, such as lipids, proteins, and nucleic acids. Increased ROS produce oxidized low-density lipoproteins (ox-LDL), which, in turn, induce atherosclerosis and subsequent cardiovascular disease. Cardiovascular disease is the leading cause of death of HD patients. On the other hand, ROS damage RBC membrane and cause hemolysis. Hemolysis exaggerates uremic anemia and results in resistance to erythropoietin (EPO) therapy. Acetylcysteine, a common mucolytic, is an antioxidant as well. In vivo experiments, acetylcysteine has been demonstrated to inhibit the production of ox-LDL by ROS. Acetylcysteine has also been shown as an effective drug for prevention of contrast media-induced nephropathy in high-risk patients. Thus we hypothesize HD patients taking acetylcysteine may have less ox-LDL produced by ROS and, consequently, lower risk of cardiovascular disease. Moreover, having less damage to RBC membrane by ROS, HD patients taking acetylcysteine may have milder anemia and better responsiveness to erythropoietin therapy. Therefore, we plan to conduct a prospective trial, in which acetylcysteine is administrated to the enrolled HD patients for three months. The primary goals of the study are to realize the changes of 1) plasma ox-LDL levels, 2) the anemia status, 3) the responsiveness to EPO therapy, and 4) severity of atherosclerosis. The secondary goals are to identify the changes of oxidative stress and pro-inflammatory status in the patients.
Trial information was received from ClinicalTrials.gov and was last updated in October 2006.
Information provided to ClinicalTrials.gov by Far Eastern Memorial Hospital.