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CoQ10 and Exercise for Mitochondrial Dysfunction in Advance Kidney Disease

NCT05422534 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2026-01-02

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

CoQ10

Participants will receive 1800 mg/day for 12 weeks

DRUG

Placebo

Participants will receive placebo or CoQ10/day for 12 weeks

BEHAVIORAL

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.

BEHAVIORAL

Observational

Participant regular activities

Sponsors & Collaborators

  • University of California, Davis

    collaborator OTHER

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Jorge Gamboa, MD/PhD · VUMC

  • Talat Ikizler, MD · VUMC

  • Baback Roshanravan, MD/MPH · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2027-06-20
Completion
2027-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05422534 on ClinicalTrials.gov