End Stage Renal DiseaseNCT00410449
Oxidative Stress and Hemodialysis Access Failure
An observational study of End Stage Renal Disease and Hemodialysis, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial summary
Complications of hemodialysis access are the most frequent single reason for hospitalization among patients with End Stage Renal Disease (ESRD). Uremia, and particularly uremia in patients with diabetes, is a state of increased oxidative stress. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- End Stage Renal Disease, Hemodialysis
- What is being tested?
- Alpha tocopherol
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- May 2001to May 2004
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults, end stage renal disease treated by hemodialysis, patent hemodialysis vascular access (graft or fistula)
Who cannot join
- Temporary catheter dialysis access, inability to be compliant with study medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Effect of Oral Supplementation With Vitamin E on Circulating Oxidative Markers, Hemodialysis Vascular Access Occlusion, and Clinical Events in Patients With End Stage Renal Failure Treated by Hemodialysis
Complications of hemodialysis access are the most frequent single reason for hospitalization among patients with End Stage Renal Disease (ESRD). Uremia, and particularly uremia in patients with diabetes, is a state of increased oxidative stress. The central hypothesis to be tested by this project is that oxidative stress is a major (and modifiable) trigger for vascular access complications. We hope to slow or reduce rates of stenosis, thrombosis and access complications by giving Vitamin E supplementation to patients being treated by hemodialysis.
Read the detailed description
Patients continued their usual treatment on hemodialysis three times per week. This was a double-blinded placebo controlled trial. Patients took either Vitamin E 400 IU bid or placebo. An initial evaluation of access patency was performed and baseline blood drawn before starting Vitamin E. Every 3 months there was a followup evaluation with blood drawn for oxidative stress markers, and with a test of vascular access patency. The study was closed to new participants, vitamin E or placebo stopped, and data analysis performed in 2003.
- Conditions
- End Stage Renal Disease, Hemodialysis
- Being tested
- Alpha tocopherol
- Keywords
- End stage renal disease treated by hemodialysis, Hemodialysis vascular access patency, Vitamin E, oxidative markers, pentosidine, hydroxynonenal, levuglandin
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha tocopherolDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2006 (estimated)
- Study startMay 2001
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 35 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Leonard B Rosenberg Renal Research Foundation
- Investigators
- Miriam F Weiss, M.D., Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00410449
- Sponsor's protocol ID
- 11461-CP-001
- Other IDs
- NIEHS ES11461
- Status last verified
- Dec 2006
- First submitted
- 11 Dec 2006
- Last updated
- 6 Oct 2015
- Results posted
- No
Publications
Schwing WD, Erhard P, Newman LN, Nodge MM, Czechanski BJ, Orlin SM, Walden SM, Behm K, Cacho CP, Negrea LA, Siu DS, Kern EO, Weiss MF. Assessing 24-hour blood glucose patterns in diabetic paitents treated by peritoneal dialysis. Adv Perit Dial. 2004;20:213-6.
PubMed 15384829
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of Oral Supplementation With Vitamin E on Circulating Oxidative Markers, Hemodialysis Vascular Access Occlusion, and Clinical Events in Patients With End Stage Renal Failure Treated by Hemodialysis
- ClinicalTrials.gov ID
- NCT00410449
- Acronym / sponsor ID
- 11461-CP-001
- Conditions
- End Stage Renal Disease, Hemodialysis
- Keywords
- End stage renal disease treated by hemodialysis, Hemodialysis vascular access patency, Vitamin E, oxidative markers, pentosidine, hydroxynonenal, levuglandin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Collaborators
- Leonard B Rosenberg Renal Research Foundation
- Study start
- May 2001
- Study completion
- May 2004
- First posted
- 12 Dec 2006 (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.
Complications of hemodialysis access are the most frequent single reason for hospitalization among patients with End Stage Renal Disease (ESRD). Uremia, and particularly uremia in patients with diabetes, is a state of increased oxidative stress. The central hypothesis to be tested by this project is that oxidative stress is a major (and modifiable) trigger for vascular access complications. We hope to slow or reduce rates of stenosis, thrombosis and access complications by giving Vitamin E supplementation to patients being treated by hemodialysis.
Detailed description
Patients continued their usual treatment on hemodialysis three times per week. This was a double-blinded placebo controlled trial. Patients took either Vitamin E 400 IU bid or placebo. An initial evaluation of access patency was performed and baseline blood drawn before starting Vitamin E. Every 3 months there was a followup evaluation with blood drawn for oxidative stress markers, and with a test of vascular access patency. The study was closed to new participants, vitamin E or placebo stopped, and data analysis performed in 2003.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults, end stage renal disease treated by hemodialysis, patent hemodialysis vascular access (graft or fistula)
Key exclusion criteria (1 listed)
- Temporary catheter dialysis access, inability to be compliant with study medication
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 |
|---|---|---|
| Alpha tocopherol | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
- Results publication: PubMed 15384829Schwing WD, Erhard P, Newman LN, Nodge MM, Czechanski BJ, Orlin SM, Walden SM, Behm K, Cacho CP, Negrea LA, Siu DS, Kern EO, Weiss MF. Assessing 24-hour blood glucose patterns in diabetic paitents treated by peritoneal dialysis. Adv Perit Dial. 2004;20:213-6.
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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.
Miriam F Weiss, M.D. principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease and Hemodialysis, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Oct 2015. 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 United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00410449, which also lists 1 linked publication.
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 6 Oct 2015.