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.
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
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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…
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