NCT05422534RecruitingPhase 3

CoQ10 and Exercise for Mitochondrial Dysfunction in Advance Kidney Disease

Role of Mitochondrial Dysfunction in the Response to Exercise in Patients With Advance Kidney Disease

Source: ClinicalTrials.gov · Last updated 2 Jan 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Phase (registry): Phase 3
Study type: Interventional
Enrollment: 156 (estimated)
First submitted: 13 Jun 2022
Start date: 1 Jun 2023
Primary completion date: 20 Jun 2027
Lead sponsor: Vanderbilt University Medical Center
Diseases: Chronic kidney disease
NCT number: NCT05422534

What you commit to

Study type: Interventional · Phase 3
Planned participants: 156
From 1 Jun 2023 to the primary completion date, 20 Jun 2027
2 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

History of functional transplant less than 6 months prior to study
Use of immunosuppressive drugs within 1 month prior to study
Acute infectious disease within 1 month prior to study
Anticipated live donor kidney transplant

Other illness

Active connective tissue disease
AIDS (HIV seropositivity is not an exclusion criterion)
Acute myocardial infarction or cerebrovascular event within 3 months
Prolonged ongoing (greater than 20 minutes) angina at rest
Angina at rest with transient ST changes greater than 0.05 mV 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.
Active malignancy excluding basal cell carcinoma of the skin
History of poor adherence to hemodialysis or medical regimen
Subjects with cardiac pacemaker, artificial heart valve, any metallic implant, permanent tattoo, or any retained foreign metallic bodies.
Contraindication for exercise such as electrolyte abnormalities, uncontrolled arrhythmias, or pulmonary congestion.

Lab values

Ejection fraction less than 30%
Pre-dialysis potassium repeatedly higher than 5.5 mmol/L (confirmed on a repeated blood draw)

Other

Body mass index \> 35 mg/kg2
Uncontrolled blood pressure
New or worsening mitral regurgitation murmur
Hypotension, bradycardia, or tachycardia
Sustained ventricular tachycardia on ECG
Gastrointestinal dysfunction requiring parental nutrition
Inability to provide consent
Inability to perform exercise

Who the study is looking for

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)

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Save your city in your profile to sort them by distance.

Site	City	Country	Site status
Vanderbilt University Medical Center-GCRC Coordinator of this site? Confirm its status	Nashville	United States	Recruiting
University of California Davis Health Coordinator of this site? Confirm its status	Sacramento	United States	Not yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.