CoQ10 and Exercise for Mitochondrial Dysfunction in Advance Kidney Disease

NCT05422534 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 221073
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• PCr recovery measured by 31 phosphorus magnetic resonance spectroscopy

  ERSD 38.7 +/- 5.9 seconds ,with HIIT alone 3.87 sec, with HIIT and CoQ10 11.61.sec

  12 weeks

Secondary Outcomes (1)

• Six minute walk test

  12 weeks

Study Arms (4)

Observational + placebo

PLACEBO COMPARATOR

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

Drug: Placebo; Behavioral: Observational

Observational+ CoQ10

ACTIVE COMPARATOR

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

Dietary Supplement: CoQ10; Behavioral: Observational

HB HIIT +placebo

PLACEBO COMPARATOR

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).

Drug: Placebo; Behavioral: HB-HIIT

HB HIIT + CoQ10

ACTIVE COMPARATOR

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).

Dietary Supplement: CoQ10; Behavioral: HB-HIIT

Interventions

CoQ10 DIETARY_SUPPLEMENT

Participants will receive 1800 mg/day for 12 weeks

Also known as: ubiquinone

HB HIIT + CoQ10; Observational+ CoQ10

Placebo DRUG

Participants will receive placebo or CoQ10/day for 12 weeks

Also known as: inactive substance

HB HIIT +placebo; Observational + placebo

HB-HIIT BEHAVIORAL

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.

Also known as: exercise

HB HIIT + CoQ10; HB HIIT +placebo

Observational BEHAVIORAL

Participant regular activities

Also known as: Normal Routine

Observational + placebo; Observational+ CoQ10

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• University of California, Davis: collaborator

Study Sites (2)

University of California Davis Health

Sacramento, California, 95817, United States

NOT YET RECRUITING

Vanderbilt University Medical Center-GCRC

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic; Mitochondrial Diseases; Sarcopenia; Frailty; Motor Activity

Interventions

coenzyme Q10; Ubiquinone; Exercise; Watchful Waiting

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Metabolic Diseases; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Benzoquinones; Quinones; Organic Chemicals; Coenzymes; Enzymes and Coenzymes; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Jorge Gamboa, MD/PhD

  VUMC

  PRINCIPAL INVESTIGATOR

• Talat Ikizler, MD

  VUMC

  PRINCIPAL INVESTIGATOR

• Baback Roshanravan, MD/MPH

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Delia M Woods, BSN/MSL

CONTACT

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

Patricia Wright, BSN

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The randomization will be accomplished through a 2-step procedure. In Step 1, subjects will be randomized to one of the two treatment arms (HIIT and observation) using a permuted-block randomization algorithm. In Step 2, subjects will be randomized to receive either CoQ10 supplement or placebo. Investigators cannot be blinded to HIIT or observation assignments. To avoid bias, study personnel will be blinded to this assignment as much as possible while collecting data at rest during the study visits. Study personnel will be blinded to the study drug assignment that has been determined by the Step 2 randomization schedule.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Model Details: Randomized, doubled-blinded, 2x2 factorial design, placebo-controlled clinical trial

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 16, 2022
• Study Start: June 1, 2023
• Primary Completion (Estimated): June 20, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)