Chronic Renal FailurePhase 4NCT00307996
The Effect of CoQ10 Administration on Hemodialysis Patients
A Phase 4 study testing Coenzyme Q10 (drug) in people with Chronic Renal Failure and Hemodialysis, run by University of Shizuoka at 1 site in Japan.
Trial summary
The purpose of this study is to examine whether CoQ10 administration is effective as an antioxidant in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 0 to 85 years
- Conditions the study is for
- Chronic Renal Failure, Hemodialysis
- What is being tested?
- Coenzyme Q10 (drug)
- How many people
- 40 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2004to Dec 2004
- 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 0 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- hemodialysis for at least 6 months
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of CoQ10 Administration on the Oxidative and Antioxidative Markers in Hemodialysis Patients
The purpose of this study is to examine whether CoQ10 administration is effective as an antioxidant in hemodialysis patients.
Read the detailed description
Oxidative stress has been recognized as a potential risk factor for such complications as atherosclerosis in hemodialysis patients. This study investigates whether CoQ10 administration is effective for protecting oxidative stress in hemodialysis patients. The subjects were recruited from day-time hemodialysis patients in Iwata City Hospital. 100 mg CoQ10 was administered every HD for 6 months. Several oxidative and antioxidative markers were measured in plasma at pre, 1, 3, 6 months and after washout.
- Conditions
- Chronic Renal Failure, Hemodialysis
- Being tested
- Coenzyme Q10 (drug)
- Keywords
- CoQ10, hemodialysis, oxidative marker, antioxidant
- 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.
Coenzyme Q10 (drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative protein concentration at 6 month
Antioxidant capacity at 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2006 (estimated)
- Study startMar 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies 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)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- University of Shizuoka
- Sponsor type
- University, hospital or other
- Investigators
- Hiromichi Kumagai, MD, Study chair, University of Shizuoka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00307996
- Sponsor's protocol ID
- CT2006001
- Status last verified
- Mar 2006
- First submitted
- 27 Mar 2006
- Last updated
- 28 Mar 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of CoQ10 Administration on the Oxidative and Antioxidative Markers in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT00307996
- Acronym / sponsor ID
- CT2006001
- Conditions
- Chronic Renal Failure, Hemodialysis
- Keywords
- CoQ10, hemodialysis, oxidative marker, antioxidant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- University of ShizuokaUniversity, hospital or other
- Study start
- Mar 2004
- Study completion
- Dec 2004
- First posted
- 28 Mar 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.
The purpose of this study is to examine whether CoQ10 administration is effective as an antioxidant in hemodialysis patients.
Detailed description
Oxidative stress has been recognized as a potential risk factor for such complications as atherosclerosis in hemodialysis patients. This study investigates whether CoQ10 administration is effective for protecting oxidative stress in hemodialysis patients. The subjects were recruited from day-time hemodialysis patients in Iwata City Hospital. 100 mg CoQ10 was administered every HD for 6 months. Several oxidative and antioxidative markers were measured in plasma at pre, 1, 3, 6 months and after washout.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 0 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- hemodialysis for at least 6 months
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Coenzyme Q10 (drug) | Drug | – |
Primary outcome
Oxidative protein concentration at 6 month
Antioxidant capacity at 6 month
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 28 Mar 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.
Hiromichi Kumagai, MD study chair
University of Shizuoka
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 Coenzyme Q10 (drug) in people with Chronic Renal Failure and Hemodialysis, run by University of Shizuoka at 1 site in Japan.
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 28 Mar 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 Japan. 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?
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.
What does the primary outcome measure?
Oxidative protein concentration at 6 month. The study lists 2 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 28 Mar 2006.