NCT00908297

Brief Summary

The purpose of this study is to determine the safety and tolerability of the dietary supplement Coenzyme Q10 in hemodialysis patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2010

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

May 21, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 25, 2009

Completed
8 months until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

April 24, 2012

Status Verified

April 1, 2012

Enrollment Period

8 months

First QC Date

May 21, 2009

Last Update Submit

April 20, 2012

Conditions

Cardiovascular DiseaseEnd Stage Renal DiseaseAtherosclerosisOxidative Stress

Keywords

Cardiovascular diseaseEnd stage renal diseaseAtherosclerosisOxidative stressAntioxidants

Outcome Measures

Primary Outcomes (2)

  • Safety Measures: * Laboratory tests on serum: Comprehensive metabolic panel and creatinine phosphokinase. * Electrocardiogram, physical examination findings, and adverse events.

    Every two weeks

  • Efficacy Measures: Markers in the blood indicating "oxidative stress"

    Every two weeks

Secondary Outcomes (1)

  • Serum biomarkers of Cardiovascular condition and health

    At baseline study visit and last study visit

Interventions

Coenzyme Q10DIETARY_SUPPLEMENT

By mouth (wafer) once daily for duration of study (8 weeks). Dose escalation: * 300 mg for two weeks * 600 mg for two weeks * 1200 mg for two weeks * 1800 mg for final two weeks

Also known as: CoQ10

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with end-stage renal disease receiving thrice weekly hemodialysis
  • Age \> 18 and \< 85 years
  • Life expectancy greater than one year
  • Ability to understand and provide informed consent for participation in the study
  • Mean baseline plasma F2-isoprostane concentration \> 50 pg/mL

You may not qualify if:

  • History of poor adherence to hemodialysis or medical regimen
  • Prisoners, patients with significant mental illness, and other vulnerable populations
  • 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
  • Patients taking vitamin E supplements \> 60 IU/day, vitamin C \> 50 mg/day or other antioxidant or nutritional supplements
  • Incident hemodialysis patients (defined as within 90 days of dialysis initiation)
  • Patients hospitalized within the past 60 days
  • Patients being dialyzed with a tunneled catheter as a temporary vascular access
  • Patients with a history of a major atherosclerotic event (defined as combined incidence of myocardial infarction, urgent target-vessel revascularization, coronary bypass surgery, and stroke) within six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwest Kidney Centers - Scribner

Seattle, Washington, 98122, United States

Location

Related Publications (1)

  • Yeung CK, Billings FT 4th, Claessens AJ, Roshanravan B, Linke L, Sundell MB, Ahmad S, Shao B, Shen DD, Ikizler TA, Himmelfarb J. Coenzyme Q10 dose-escalation study in hemodialysis patients: safety, tolerability, and effect on oxidative stress. BMC Nephrol. 2015 Nov 3;16:183. doi: 10.1186/s12882-015-0178-2.

    PMID: 26531095DERIVED

Related Links

MeSH Terms

Conditions

Cardiovascular DiseasesKidney Failure, ChronicAtherosclerosis

Interventions

coenzyme Q10

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 SymptomsArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Jonathan Himmelfarb, MD

    University of Washington - Kidney Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 21, 2009

First Posted

May 25, 2009

Study Start

February 1, 2010

Primary Completion

October 1, 2010

Study Completion

November 1, 2010

Last Updated

April 24, 2012

Record last verified: 2012-04

Locations

US(1)