End-stage Renal DiseasePhase 2NCT00237718
Provision of Antioxidant Therapy in Hemodialysis (PATH) Study
A Phase 2 study testing Alpha, gamma, beta, and delta (mixed) tocopherols and Alpha lipoic acid in people with End-stage Renal Disease, run by Vanderbilt University at 1 site in United States.
Trial summary
Studies have shown that end stage renal disease (ESRD) patients have higher levels of blood markers which their body makes in response to increased stress and injury. An increase in these markers have been shown to be related to cardiovascular disease and death in ESRD patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- Alpha, gamma, beta, and delta (mixed) tocopherols and Alpha lipoic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 385 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Sep 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients with end-stage renal disease receiving thrice weekly hemodialysis
- Age > 18 years
- Life expectancy greater than one year
- Ability to understand and provide informed consent for participation in the study
Who cannot join
- AIDS (HIV seropositivity is not an exclusion criteria)
- Active malignancy excluding basal cell carcinoma of the skin
- Gastrointestinal dysfunction requiring parenteral nutrition
- History of functional kidney transplant < 6 months prior to study entry
- Anticipated live donor kidney transplant over study duration
- History of poor adherence to hemodialysis or medical regimen
Show all 11Show fewer
- Prisoners, patients with significant mental illness, pregnant women, and other vulnerable populations
- Patients taking vitamin E supplements > 60 IU/day, vitamin C > 500 mg/day over the past 30 days
- Patients taking anti-inflammatory medication except aspirin < 325 mg/day over the past 30 days
- Patients using a temporary catheter for dialysis access
- More than two hospitalizations within the last 90 days or one hospitalization within the last 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Fresenius Medical Care North America
Nashville, Tennessee, 37215
About this study
Studies have shown that end stage renal disease (ESRD) patients have higher levels of blood markers which their body makes in response to increased stress and injury. An increase in these markers have been shown to be related to cardiovascular disease and death in ESRD patients. This study will examine whether antioxidant therapy (Vitamin E and alpha lipoic acid) may decrease these markers.
Read the detailed description
Oxidative stress and acute phase inflammation are now recognized to be highly prevalent in the hemodialysis population, and several lines of evidence point to their contribution in atherosclerosis development. Biomarkers of the inflammatory state such as C-reactive protein (CRP) and interleukin-6 are robust predictors of cardiovascular events and mortality in the dialysis population. The uremic state is characterized by retention of oxidized solutes including reactive aldehyde groups and oxidized thiol groups. It has recently been demonstrated that initiation of maintenance hemodialysis does not improve biomarkers of oxidative stress or inflammation, suggesting that dialysis alone is inadequate to control the atherosclerotic uremic metabolic state. In this study we hypothesize that administration of antioxidant therapy will decrease biomarkers of acute phase inflammation and oxidative stress while improving the erythropoietic response in hemodialysis patients.
- Conditions
- End-stage Renal Disease
- Being tested
- Alpha, gamma, beta, and delta (mixed) tocopherols, Alpha lipoic acid, Placebo
- 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, gamma, beta, and delta (mixed) tocopherolsDrug
Also called Vitamin E
approximately 666 IU daily (1 pill) for 6 months
Alpha lipoic acidDrug
600 mg daily (2 pills 300 mg each) for 6 months
PlaceboDrug
placebo for alpha, gamma, beta, and delta (mixed) tocopherols; 1 pill daily for 6 months
PlaceboDrug
placebo for alpha lipoic acid; 2 pills daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| ALA and Vitamin E | Active comparator | 600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of alpha, gamma, beta and delta (mixed) tocopherols (Vitamin E) taken orally on a daily basis for 6 months Receives: Drug: Alpha, gamma, beta, and delta (mixed) tocopherols; Drug: Alpha lipoic acid |
| Placebo | Placebo comparator | placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
F2-isoprostane (F2-iso)
F2-iso is a sensitive laboratory assay for serum levels of F2-isoprostane, which is a biomarker of oxidative stress.
Measured: month 6
Secondary outcomes (1)
Interleukin-6 (IL-6)
IL-6 is a sensitive laboratory assay for serum levels of interleukin-6, which is a pro-inflammatory cytokine used to evaluate the inflammatory response.
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startApr 2006
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Medical Care North America
- Responsible party
- Principal investigator, Alp Ikizler, Vanderbilt University
- Investigators
- Jonathan Himmelfarb, MD, Principal investigator, MaineHealthAlp Ikizler, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237718
- Sponsor's protocol ID
- 050377
- Status last verified
- Jan 2012
- First submitted
- 10 Oct 2005
- Last updated
- 11 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Provision of Antioxidant Therapy in Hemodialysis (PATH) Study
- ClinicalTrials.gov ID
- NCT00237718
- Acronym / sponsor ID
- 050377
- Conditions
- End-stage Renal Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Fresenius Medical Care North America
- Study start
- Apr 2006
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 12 Oct 2005 (estimated)
- Results
- Posted 5 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Studies have shown that end stage renal disease (ESRD) patients have higher levels of blood markers which their body makes in response to increased stress and injury. An increase in these markers have been shown to be related to cardiovascular disease and death in ESRD patients. This study will examine whether antioxidant therapy (Vitamin E and alpha lipoic acid) may decrease these markers.
Detailed description
Oxidative stress and acute phase inflammation are now recognized to be highly prevalent in the hemodialysis population, and several lines of evidence point to their contribution in atherosclerosis development. Biomarkers of the inflammatory state such as C-reactive protein (CRP) and interleukin-6 are robust predictors of cardiovascular events and mortality in the dialysis population. The uremic state is characterized by retention of oxidized solutes including reactive aldehyde groups and oxidized thiol groups. It has recently been demonstrated that initiation of maintenance hemodialysis does not improve biomarkers of oxidative stress or inflammation, suggesting that dialysis alone is inadequate to control the atherosclerotic uremic metabolic state. In this study we hypothesize that administration of antioxidant therapy will decrease biomarkers of acute phase inflammation and oxidative stress while improving the erythropoietic response in hemodialysis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALA and Vitamin E | Active comparator | Drug: Alpha, gamma, beta, and delta (mixed) tocopherols, Drug: Alpha lipoic acid600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of alpha, gamma, beta and delta (mixed) tocopherols (Vitamin E) taken orally on a daily basis for 6 months |
| Placebo | Placebo comparator | Drug: Placeboplacebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with end-stage renal disease receiving thrice weekly hemodialysis
- Age > 18 years
- Life expectancy greater than one year
- Ability to understand and provide informed consent for participation in the study
Key exclusion criteria (11 listed)
- AIDS (HIV seropositivity is not an exclusion criteria)
- Active malignancy excluding basal cell carcinoma of the skin
- Gastrointestinal dysfunction requiring parenteral nutrition
- History of functional kidney transplant < 6 months prior to study entry
- Anticipated live donor kidney transplant over study duration
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, gamma, beta, and delta (mixed) tocopherolsAlso: Vitamin Eapproximately 666 IU daily (1 pill) for 6 months | Drug | ALA and Vitamin E |
| Alpha lipoic acid600 mg daily (2 pills 300 mg each) for 6 months | Drug | ALA and Vitamin E |
| Placeboplacebo for alpha, gamma, beta, and delta (mixed) tocopherols; 1 pill daily for 6 months | Drug | Placebo |
| Placeboplacebo for alpha lipoic acid; 2 pills daily for 6 months | Drug | Placebo |
Primary outcome
F2-isoprostane (F2-iso)
Time frame: month 6
F2-iso is a sensitive laboratory assay for serum levels of F2-isoprostane, which is a biomarker of oxidative stress.
1 secondary outcome
Interleukin-6 (IL-6)
Time frame: month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jonathan Himmelfarb, MD principal investigator
MaineHealth
Alp Ikizler, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alpha, gamma, beta, and delta (mixed) tocopherols and Alpha lipoic acid in people with End-stage Renal Disease, run by Vanderbilt University 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 4 inclusion and 11 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 11 Jan 2012. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
F2-isoprostane (F2-iso) (time frame: month 6). 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 11 Jan 2012.