Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT05422534

CoQ10 and Exercise for Mitochondrial Dysfunction in Advance Kidney Disease

Led by Vanderbilt University Medical Center · Updated on 2026-01-02

156

Participants Needed

2

Research Sites

226 weeks

Total Duration

On this page

Sponsors

V

Vanderbilt University Medical Center

Lead Sponsor

U

University of California, Davis

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

CoQ10 and Exercise for Mitochondrial Dysfunction in Advance Kidney Disease

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years
  • On thrice-weekly chronic hemodialysis for at least 6 months
  • Clinically stable and adequately dialyzed (single-pool Kt/V >1.2) for at least 3 consecutive months prior to the study
Not Eligible

You will not qualify if you...

  • Body mass index greater than 35 mg/kg2
  • 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)
  • Acute myocardial infarction or cerebrovascular event within 3 months
  • Uncontrolled blood pressure
  • New or worsening mitral regurgitation murmur
  • Hypotension, bradycardia, or tachycardia
  • Prolonged ongoing angina at rest (>20 minutes)
  • Angina at rest with transient ST changes >0.05 mV on ECG
  • Sustained ventricular tachycardia on ECG
  • Elevated cardiac enzymes (e.g., troponin T or I >0.1 mg/ml)
  • Advanced liver disease (Child-Turcotte-Pugh score ≥10)
  • Gastrointestinal dysfunction requiring parenteral 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
  • Anticipated live donor kidney transplant
  • History of poor adherence to hemodialysis or medical regimen
  • Inability to provide consent
  • Cardiac pacemaker, artificial heart valve, metallic implant, permanent tattoo, or retained metallic foreign bodies
  • Inability to perform exercise
  • Contraindications for exercise such as electrolyte abnormalities, uncontrolled arrhythmias, or pulmonary congestion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

University of California Davis Health

Sacramento, California, United States, 95817

Not Yet Recruiting

2

Vanderbilt University Medical Center-GCRC

Nashville, Tennessee, United States, 37232

Actively Recruiting

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Research Team

D

Delia M Woods, BSN/MSL

CONTACT

P

Patricia Wright, BSN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

PREVENTION

Number of Arms

4

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