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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining CoQ10 supplements with home-based high-intensity interval training (HIIT) can enhance muscle function and physical performance in individuals with end-stage renal disease (ESRD) on dialysis. The study will assess whether CoQ10, which targets mitochondria (the energy producers in cells), can enhance exercise effectiveness in preventing frailty and muscle loss. Participants will be divided into groups receiving either CoQ10 and exercise, a placebo and exercise, CoQ10 without exercise, or a placebo without exercise. The trial seeks individuals who have undergone regular dialysis for at least six months and are clinically stable. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CoQ10 is generally safe as a dietary supplement. Studies suggest that taking up to 1200 mg daily is unlikely to cause harm. CoQ10 may support kidney function and reduce protein loss in urine, benefiting those with kidney issues.

Research indicates that high-intensity interval training (HIIT) can be a safe and effective exercise for people with chronic kidney disease. HIIT offers benefits similar to moderate exercise and might even help slow the decline in kidney function over time.

Together, CoQ10 and HIIT appear well-tolerated by individuals with kidney problems. This trial will further investigate their combined effects on health and safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for advanced kidney disease because they combine CoQ10 supplementation with high-intensity interval training (HIIT), which are not typical components of current care options. While traditional treatments often involve medications to manage symptoms, CoQ10 is a powerful antioxidant that may protect kidney cells from damage. The addition of home-based HIIT offers a novel approach to improving physical health and potentially enhancing kidney function, all from the comfort of one's home. This combination could lead to a more comprehensive method of managing kidney disease by not just addressing symptoms but also improving overall health and resilience.

What evidence suggests that this trial's treatments could be effective for advanced kidney disease?

Studies have shown that CoQ10 can improve kidney function and reduce damage from harmful molecules in people with chronic kidney disease. It significantly lowers protein levels in urine by 88%, suggesting that CoQ10 supports kidney health. In this trial, some participants will receive CoQ10 alone, while others will receive it with HB-HIIT. Research indicates that HB-HIIT, a type of home exercise, is safe and effective for people with chronic kidney disease, improving physical fitness. Combining CoQ10 with HB-HIIT may further enhance muscle function and physical performance. This combination targets the energy centers of cells, possibly increasing the benefits of exercise for those with kidney issues. ^{1 2 4 5 6}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 (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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6530451/

Efficacy of coenzyme Q10 in patients with chronic kidney ... CoQ10 supplementation may improve mitochondrial function and decrease oxidative stress in patients undergoing haemodialysis. CoQ10 may have ...

2. kidney-international.org kidney-international.org/article/S0085-2538(22)00379-9/fulltext

Oral Coenzyme Q10 supplementation leads to better ... CoQ10 supplementation was associated with a substantial and significant sustained reduction of proteinuria by 88% at 12 months. Complete ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03579693

Trial of Nicotinamide Riboside and Co-enzyme Q10 in ... The primary purpose of this study is to test whether coQ10 and NR can improve muscle function among people with chronic kidney disease.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0085253822003799

Oral Coenzyme Q10 supplementation leads to better ... CoQ 10 supplementation led to significantly better preservation of kidney function (5-year kidney failure-free survival 62% vs. 19%)

5. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK531491/

Coenzyme Q10 - StatPearls - NCBI Bookshelf CoQ10 can potentially increase the production of vital antioxidants, such as superoxide dismutase, an enzyme that effectively mitigates vascular ...

6. mdpi.com mdpi.com/2076-3921/8/2/44

Coenzyme Q10 and Degenerative Disorders Affecting ... In addition, supplementary CoQ10 may reduce mortality risk in patients with type II diabetes, chronic kidney disease or liver disease, both by beneficial ...