CoQ10 + Exercise for Advanced Kidney Disease

Recruiting at 1 trial location

Overseen By Patricia Wright, BSN

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Vanderbilt University Medical Center

Must not be taking: Immunosuppressive drugs

Disqualifiers: BMI > 35, Active malignancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

156 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests whether combining high-intensity interval training (HIIT) with Coenzyme Q10 (CoQ10) supplements can improve muscle function in patients with end-stage renal disease (ESRD) on dialysis. HIIT helps improve energy production in cells, and CoQ10 supports this process. The goal is to see if this combination can better enhance physical performance and muscle health compared to exercise alone.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using immunosuppressive drugs, you must have stopped them at least one month before the study.

What data supports the effectiveness of the treatment CoQ10 + Exercise for Advanced Kidney Disease?

Research suggests that CoQ10, a vitamin-like substance, may help improve heart health and reduce oxidative stress in people with chronic kidney disease. However, its impact on exercise performance and kidney function is still unclear, as some studies show no significant improvement in these areas. ^{1 2 3 4 5}

Is CoQ10 safe for humans, especially those with kidney disease?

CoQ10 (also known as Ubiquinone or Coenzyme Q10) has been studied in people with chronic kidney disease and other conditions, and it is generally considered safe. In clinical trials, CoQ10 supplementation did not show harmful effects on kidney function or overall health in participants. ^{3 4 5 6 7}

How does the treatment CoQ10 + Exercise differ from other treatments for advanced kidney disease?

The CoQ10 + Exercise treatment is unique because it combines a supplement known for its antioxidative properties and role in mitochondrial metabolism with exercise, potentially improving mitochondrial function and reducing oxidative stress in patients with advanced kidney disease, unlike standard treatments that may not address these specific mechanisms. ^{1 3 4 7 8}

Research Team

Talat Ikizler, MD

Principal Investigator

VUMC

Baback Roshanravan, MD MS

Principal Investigator

University of California, Davis

Jorge Gamboa, MD/PhD

Principal Investigator

VUMC

Eligibility Criteria

This trial is for adults aged 18-75 with advanced kidney disease who have been on hemodialysis for at least 6 months and are clinically stable. It's not suitable for those with a BMI over 35, recent transplants or heart attacks, uncontrolled blood pressure, active severe diseases, certain metal implants, inability to exercise, or poor adherence to medical regimens.

Inclusion Criteria

I have been on dialysis 3 times a week for at least 6 months.

I have been on stable dialysis treatment 3 times a week for the last 3 months.

Exclusion Criteria

I have low or high blood pressure, or my heart beats too slow or fast.

I have experienced chest pain lasting more than 20 minutes while at rest.

I need nutrition through IV due to stomach or intestine problems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either placebo or CoQ10 supplementation along with standard care or home-based high-intensity interval training (HB-HIIT) for 12 weeks

12 weeks

3 visits per week (video-supervised)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CoQ10
• HB-HIIT

Trial Overview The study tests if CoQ10 supplements combined with high-intensity interval training (HB-HIIT) can improve mitochondrial function and physical performance in patients with severe kidney disease. Some participants will receive a placebo instead of CoQ10 as part of the research design.

Participant Groups

Group I: Observational+ CoQ10 Active Control 2 Interventions

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

Group II: HB HIIT + CoQ10 Active Control 2 Interventions

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).

Group III: Observational + placebo Placebo Group 2 Interventions

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

Group IV: HB HIIT +placebo Placebo Group 2 Interventions

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).

HB-HIIT is already approved in United States, European Union for the following indications:

Approved in United States as Coenzyme Q10 for:

• Mitochondrial myopathies
• Statins-induced myopathy
• Supplementation for mitochondrial function

Approved in European Union as Ubiquinone for:

• Mitochondrial myopathies
• Supplementation for mitochondrial function

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

University of California, Davis

Collaborator

Trials

958

Recruited

4,816,000+

Findings from Research

Coenzyme Q10 (CoQ10) supplementation may help reduce cardiovascular events and improve mitochondrial function in patients with chronic kidney disease (CKD), as plasma levels of CoQ10 are often low in these patients.

This systematic review aims to comprehensively assess the efficacy and safety of CoQ10 in CKD patients, utilizing a thorough methodology that includes independent screening of studies from multiple databases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of coenzyme Q10 in patients with chronic kidney disease: protocol for a systematic review. Xu, Y., Liu, J., Han, E., et al.[2020]

A 12-month supervised exercise program for older adults with advanced chronic kidney disease (CKD) was found to be safe and well-tolerated, with no significant increase in adverse events reported.

Participants in the exercise group showed significant improvements in physical functioning, including a greater distance walked in the 6-minute walk test and better performance on the Timed Up and Go Test, indicating that exercise can enhance physical capabilities in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Long-term Exercise Training on Physical Performance and Cardiorespiratory Function in Adults With CKD: A Randomized Controlled Trial. Weiner, DE., Liu, CK., Miao, S., et al.[2023]

Coenzyme Q10 (CoQ10) supplementation in chronic kidney disease (CKD) patients showed significant reductions in markers of oxidative stress and inflammation, specifically lowering malonaldehyde and high-sensitivity C-reactive protein levels.

CoQ10 supplementation also improved glucose metabolism, evidenced by reductions in HbA1c and increases in QUICKI scores, although it did not affect lipid profiles such as total cholesterol or triglycerides.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review for the efficacy of coenzyme Q10 in patients with chronic kidney disease. Xu, Y., Yang, G., Zuo, X., et al.[2022]

In a clinical trial involving 25 patients with chronic kidney disease, neither coenzyme Q10 (CoQ10) nor nicotinamide riboside (NR) improved aerobic capacity or work efficiency after 6 weeks of treatment, indicating limited efficacy for enhancing exercise tolerance in this population.

However, both supplements positively influenced metabolic markers, with NR decreasing certain lipid levels and altering TCA cycle intermediates, suggesting potential benefits for mitochondrial metabolism despite not improving physical performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized crossover clinical trial of coenzyme Q10 and nicotinamide riboside in chronic kidney disease. Ahmadi, A., Begue, G., Valencia, AP., et al.[2023]

Coenzyme Q10 (CoQ10) supplementation significantly improved the metabolic profile of patients with Chronic Kidney Disease (CKD) by reducing total cholesterol, LDL-cholesterol, malondialdehyde, and creatinine levels, based on a meta-analysis of 7 randomized controlled trials involving 721 potential studies.

However, CoQ10 did not have a significant effect on other metabolic markers such as fasting glucose, insulin levels, or C-reactive protein concentrations, indicating its specific benefits in lipid and oxidative stress management in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Coenzyme Q10 Supplementation on Metabolic Profiles of Patients with Chronic Kidney Disease: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Bakhshayeshkaram, M., Lankarani, KB., Mirhosseini, N., et al.[2019]

In a study of 150 STEMI patients undergoing primary PCI, CoQ10 supplementation significantly reduced the incidence of contrast-induced acute kidney injury (CI-AKI) compared to placebo, with 8% of the CoQ10 group experiencing CI-AKI versus 20% in the placebo group.

The CoQ10 group also showed lower serum creatinine levels at 48 and 72 hours post-procedure and improved antioxidant status, indicated by higher levels of superoxide dismutase and total antioxidant capacity, suggesting a protective effect against kidney injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of contrast induced-acute kidney injury using coenzyme Q10 in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention. Ahmadimoghaddam, D., Talebi, SS., Rahmani, A., et al.[2023]

Coenzyme Q10 (CoQ10) supplementation significantly increased serum CoQ10 levels in hemodialysis patients, but did not improve exercise performance as measured by walking distance or estimated VO2max.

The study found no significant differences in oxidative stress markers between the CoQ10 and placebo groups, indicating that CoQ10 supplementation did not affect oxidative stress levels during exercise in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Coenzyme Q10 Supplementation on Exercise Performance and Markers of Oxidative Stress in Hemodialysis Patients: A Double-Blind Placebo-Controlled Crossover Trial. Gokbel, H., Turk, S., Okudan, N., et al.[2022]

Coenzyme Q10 (Q10) supplementation during 6 weeks of exercise training in rats significantly reduced levels of the inflammatory marker NFκB and increased levels of protective proteins IκB, Nrf2, and HO-1, suggesting an anti-inflammatory effect and enhanced antioxidant defense.

The study found that Q10 did not significantly alter metabolic parameters like protein, carbohydrate, and lipid metabolism, but it did further decrease plasma triglycerides, indicating its potential role in lipid metabolism during exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coenzyme Q10 Supplementation Modulates NFκB and Nrf2 Pathways in Exercise Training. Pala, R., Orhan, C., Tuzcu, M., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy of coenzyme Q10 in patients with chronic kidney disease: protocol for a systematic review. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of Long-term Exercise Training on Physical Performance and Cardiorespiratory Function in Adults With CKD: A Randomized Controlled Trial. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

A systematic review for the efficacy of coenzyme Q10 in patients with chronic kidney disease. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Randomized crossover clinical trial of coenzyme Q10 and nicotinamide riboside in chronic kidney disease. [2023]

5. United Arab Emirates pubmed.ncbi.nlm.nih.gov

The Effects of Coenzyme Q10 Supplementation on Metabolic Profiles of Patients with Chronic Kidney Disease: A Systematic Review and Meta-analysis of Randomized Controlled Trials. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

Prevention of contrast induced-acute kidney injury using coenzyme Q10 in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Effects of Coenzyme Q10 Supplementation on Exercise Performance and Markers of Oxidative Stress in Hemodialysis Patients: A Double-Blind Placebo-Controlled Crossover Trial. [2022]

8. Turkey pubmed.ncbi.nlm.nih.gov

Coenzyme Q10 Supplementation Modulates NFκB and Nrf2 Pathways in Exercise Training. [2018]