Using CoQ10 and exercise to improve muscle function in kidney disease patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the combined effects of CoQ10, a mitochondrial-targeted therapy, and high-intensity interval training (HIIT) on improving mitochondrial function and physical performance in patients with end-stage renal disease (ESRD) undergoing maintenance hemodialysis. It aims to address frailty and sarcopenia, which are common and serious conditions in this population. By understanding how CoQ10 and exercise interact, the study seeks to enhance the effectiveness of exercise interventions and ultimately improve patient outcomes. The trial will include a comparison between CoQ10, placebo, and HIIT interventions.

Why it matters

Who can join: the full rules

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.

Where it's running

• Vanderbilt University Medical Center-GCRC
  Nashville, Tennessee, United States Recruiting
• University of California Davis Health
  Sacramento, California, United States Not yet recruiting

Study contacts

• Principal investigator: Jorge Gamboa, MD/PhD — Vumc
• Study coordinator: Delia M Woods, BSN/MSL
• Email: delia.woods@vumc.org
• Phone: 615-322-1749

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.