AnemiaPhase 4NCT00247507
The Effects of Acetylcysteine on Alleviating Damage of Oxidative Stress in Hemodialysis Patients
A Phase 4 study testing acetylcysteine in people with Anemia and Atherosclerosis, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Atherosclerosis, End-Stage Renal Disease
- What is being tested?
- acetylcysteine
- How many people
- Not given
- Where
- 1 siteTaiwan
- Study dates
- Sep 2005to Dec 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Being tested
- acetylcysteine
- Keywords
- Anemia, atherosclerosis, End-stage renal disease, Erythropoietin, Hemodialysis, Oxidative stress, Pro-inflammation
- Medical subject headings
- Anemia, Atherosclerosis, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetylcysteineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
the changes of plasma ox-LDL levels
the changes of anemia status
the responsiveness to EPO therapy and severity of atherosclerosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2005 (estimated)
- Study startSep 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Shih-Ping Hsu, M.D., Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247507
- Sponsor's protocol ID
- 94029
- Status last verified
- Oct 2005
- First submitted
- 31 Oct 2005
- Last updated
- 18 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Acetylcysteine on Alleviating Damage of Oxidative Stress in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT00247507
- Acronym / sponsor ID
- 94029
- Keywords
- Anemia, atherosclerosis, End-stage renal disease, Erythropoietin, Hemodialysis, Oxidative stress, Pro-inflammation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Sep 2005
- Study completion
- Dec 2005
- First posted
- 2 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acetylcysteine | Drug | – |
Primary outcome
the changes of plasma ox-LDL levels
the changes of anemia status
the responsiveness to EPO therapy and severity of atherosclerosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shih-Ping Hsu, M.D. principal investigator
Far Eastern Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing acetylcysteine in people with Anemia and Atherosclerosis, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the changes of plasma ox-LDL levels. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2006.