Recruiting

Phase 3

CoQ10 & ExerciseCoQ10 and Exercise for Mitochondrial Dysfunction in Advance Kidney Disease

Sponsor:

Vanderbilt University Medical Center

Code:

NCT05422534

Conditions

End Stage Renal Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

CoQ10

Placebo

HB-HIIT

Observational

Study Details

Brief summary:

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

End Stage Renal Disease

Study ID

NCT05422534

Start date

Jun 1, 2023

Status verified date

Dec, 2025

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Jun 20, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

156 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

placebo comparator: Observational + placebo

Participants will receive placebo with standard of care or regular activity for 12 weeks.

active comparator: Observational+ CoQ10

Participants will receive CoQ10 1800 mg/day with standard of care or regular activity for 12 weeks.

placebo comparator: HB HIIT +placebo

Participants will receive placebo and home based high intensity interval training for 12 weeks. Exercise will be performed on a non-dialysis day, it will be video-supervised exercise sessions, three days per week for 12 weeks. The three weekly sessions will include: 1 session of 1) body weight high-intensity interval training (bodyweight HIIT), 2) strength training, and 3) walking high-intensity interval training (walking HIIT).

active comparator: HB HIIT + CoQ10

Participants will received CoQ10 1800/day with home based high intensity interval training for 12 weeks. Exercise will be performed on a non-dialysis day, it will be video-supervised exercise sessions, three days per week for 12 weeks The three weekly sessions will include: 1 session of 1) body weight high-intensity interval training (bodyweight HIIT), 2) strength training, and 3) walking high-intensity interval training (walking HIIT).

Interventions

CoQ10

Participants will receive 1800 mg/day for 12 weeks

Placebo

Participants will receive placebo or CoQ10/day for 12 weeks

HB-HIIT

Participants will be performed on non dialysis days. It will be video supervised exercise sessions with self directed exercises using pre-recorded bodyweight and strength exercise videos.

Observational

Participant regular activities

Primary outcome measure

PCr recovery measured by 31 phosphorus magnetic resonance spectroscopy [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Delia M Woods, BSN/MSL

615-322-1749 delia.woods@vumc.org

Patricia Wright, BSN

615-322-8837 patricia.wright@vumc.org

Locations

Vanderbilt University Medical Center-GCRC

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Delia Woods, RN

delia.woods@vumc.org

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Jan 2, 2026

Last verified

Dec, 2025

Keywords

mitochondrial dysfunction
CoQ10
sarcopenia
frailty
High-intensity interval training (HIIT)
exercise
magnetic resonance spectroscopy (P-MRS)
physical performance tests

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-01-02.