NCT00410449

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2001

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2001

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 12, 2006

Completed
Last Updated

October 6, 2015

Status Verified

December 1, 2006

First QC Date

December 11, 2006

Last Update Submit

October 5, 2015

Conditions

End Stage Renal DiseaseHemodialysis

Keywords

End stage renal disease treated by hemodialysisHemodialysis vascular access patencyVitamin Eoxidative markerspentosidinehydroxynonenallevuglandin

Interventions

Alpha tocopherolDRUG

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults, end stage renal disease treated by hemodialysis, patent hemodialysis vascular access (graft or fistula)

You may not qualify if:

  • Temporary catheter dialysis access, inability to be compliant with study medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Dialysis Care

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

  • 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.

    PMID: 15384829RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

alpha-Tocopherol

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TocopherolsVitamin EBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Miriam F Weiss, M.D.

    Case Western Reserve University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

December 11, 2006

First Posted

December 12, 2006

Study Start

May 1, 2001

Study Completion

May 1, 2004

Last Updated

October 6, 2015

Record last verified: 2006-12

Locations

US(1)