CoQ10 and Exercise for End Stage Renal Disease

CoQ10 and Exercise for Mitochondrial Dysfunction in Advance Kidney Disease

Recruiting Phase 3 Interventional Study
End Stage Renal Disease
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
156 (estimated)
Sponsor
Vanderbilt University Medical Center · Other
Who this trial is looking for

This trial is looking for adults with end stage renal disease who are on dialysis. Participants will engage in high-intensity exercise and take CoQ10 to see if it helps improve muscle function and physical performance.

Are You a Good Fit for This Trial?
Rules you out Uncontrolled blood pressureHeart valve problemsSevere liver diseaseActive cancer

You may be able to join if

  • I am between 18 and 75 years old.
  • I have been on dialysis three times a week for at least 6 months.
  • I am clinically stable and have been well dialyzed for at least 3 months.

You may not be able to join if

  • I have a body mass index over 35.
  • I have had a functional kidney transplant in the last 6 months.
  • I have taken immunosuppressive drugs in the past month.
  • I have active connective tissue disease.
  • I have had an acute infectious disease in the last month.
  • I have had a heart attack or stroke within the last 3 months.
  • I cannot perform exercise.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
Frailty and sarcopenia are modifiable risk factors for morbidity and mortality in patients with ESRD. Exercise is the recommended intervention to prevent frailty and sarcopenia, however, many clinical trials have shown limited clinical improvement in muscle mass and physical function. We propose that mitochondrial dysfunction is one of the deterrents to the effectiveness of the exercise. We plan t…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Subjects age 18 to 75 years * On thrice-weekly chronic hemodialysis for at least 6 months (only applicable for patients with ESRD on maintenance hemodialysis). * Clinically stable, adequately dialyzed (single-pool Kt/V \>1.2) thrice weekly, for at least 3 consecutive months pr…
Contacts

Delia M Woods, BSN/MSL

615-322-1749

delia.woods@vumc.org

CONTACT

Patricia Wright, BSN

615-322-8837

patricia.wright@vumc.org

CONTACT