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 outUncontrolled 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.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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 to evaluate the additive effect of HIIT and CoQ10, a mitochondrial-targeted therapy, on mitochondrial function and physical performance. Understanding the interplay among CoQ10, exercise, and mitochondrial function will identify novel mechanisms to improve the efficiency of exercise. This will also serve to prevent frailty, sarcopenia, and muscle dysfunction in patients with ESRD.
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…
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 prior to the study (only applicable for patients with ESRD on maintenance hemodialysis)
Exclusion Criteria:
* Body mass index \> 35 mg/kg2
* History of functional transplant less than 6 months prior to study
* Use of immunosuppressive drugs within 1 month prior to study
* Active connective tissue disease
* Acute infectious disease within 1 month prior to study
* AIDS (HIV seropositivity is not an exclusion criterion)
* Acute myocardial infarction or cerebrovascular event within 3 months
* Uncontrolled blood pressure
* New or worsening mitral regurgitation murmur
* Hypotension, bradycardia, or tachycardia
* Prolonged ongoing (greater than 20 minutes) angina at rest
* Angina at rest with transient ST changes greater than 0.05 mV on ECG
* Sustained ventricular tachycardia on ECG
* Elevated cardiac enzymes (e.g., troponin Tor I greater than 0.1mg/ml)
* Advanced liver disease, with a modified Child-Turcotte-Pugh score equal or greater than 10.
* Gastrointestinal dysfunction requiring parental nutrition
* Active malignancy excluding basal cell carcinoma of the skin
* Ejection fraction less than 30%
* Pre-dialysis potassium repeatedly higher than 5.5 mmol/L (confirmed on a repeated blood draw)
* Anticipated live donor kidney transplant
* History of poor adherence to hemodialysis or medical regimen
* Inability to provide consent
* Subjects with cardiac pacemaker, artificial heart valve, any metallic implant, permanent tattoo, or any retained foreign metallic bodies.
* Inability to perform exercise
* Contraindication for exercise such as electrolyte abnormalities, uncontrolled arrhythmias, or pulmonary congestion.
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