What side effects are associated with this type of intervention?

Common treatments for kidney failure include dialysis, kidney transplantation, and medications to manage symptoms and complications. Dialysis can cause side effects such as low blood pressure, muscle cramps, and infections. Kidney transplantation may lead to rejection, infections, and complications from immunosuppressive drugs. For treatments similar to CoQ10 and HIIT, CoQ10 is generally well-tolerated but can cause mild side effects like gastrointestinal discomfort and headaches. High-Intensity Interval Training (HIIT) is effective in improving physical performance but may lead to muscle soreness, fatigue, and a higher risk of injury if not properly supervised.

What prior FDA approvals exist?

FDA-approved treatments for kidney failure primarily include medications to manage symptoms and complications, such as antihypertensives, erythropoiesis-stimulating agents, and phosphate binders. While CoQ10 and HIIT are being studied for their potential benefits in improving mitochondrial function and physical performance in kidney disease patients, they are not yet FDA-approved for this indication. Current research is exploring their efficacy, but more evidence is needed before they can be considered standard treatments.

What other types of research exist?

Promising novel alternatives to CoQ10 and HIIT for kidney failure patients include: 1) L-carnitine supplementation, which has shown significant increases in muscle quantity in dialysis patients. 2) Nandrolone decanoate, an anabolic steroid that has demonstrated improvements in muscle mass and strength. 3) Intradialytic exercise programs, which involve physical activity during dialysis sessions and have been shown to modify measures of sarcopenia. These alternatives offer potential benefits in enhancing mitochondrial function and physical performance in ESRD patients.

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Behavioural Intervention

CoQ10 + Exercise for Advanced Kidney Disease

Phase 3

Recruiting

Led By Talat Ikizler, MD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

On thrice-weekly chronic hemodialysis for at least 6 months (only applicable for patients with ESRD on maintenance hemodialysis)

Subjects age 18 to 75 years

Must not have

Prolonged ongoing (greater than 20 minutes) angina at rest

Gastrointestinal dysfunction requiring parental nutrition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from CoQ10 may include mild upset stomach, loss of appetite, nausea, vomiting, and diarrhea. Exercise might cause muscle soreness or increase the risk of injury if not done properly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 18 and 75 years old.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have not had an infection in the last month.

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I have cancer, but it's not just skin cancer.

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I have an active connective tissue disease.

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I am expected to receive a kidney from a living donor.

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I had an organ transplant less than 6 months ago.

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

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I have a new or worsening heart murmur.

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I have chest pain at rest with specific changes in my heart's electrical activity.

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I am unable to give consent by myself.

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I haven't taken immunosuppressive drugs in the last month.

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My blood pressure is not well-managed.

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I cannot perform physical exercises.

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My liver disease is severe, with a high Child-Pugh score.

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I cannot exercise due to heart rhythm problems or lung issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PCr recovery measured by 31 phosphorus magnetic resonance spectroscopy

Secondary study objectives

Six minute walk test

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Observational+ CoQ10Active Control2 Interventions

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

Group II: HB HIIT + CoQ10Active Control2 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 + placeboPlacebo Group2 Interventions

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

Group IV: HB HIIT +placeboPlacebo Group2 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).

0 / 19Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for kidney failure, such as CoQ10 and high-intensity interval training (HIIT), focus on improving mitochondrial function and physical performance. CoQ10 enhances mitochondrial efficiency, reducing oxidative stress and improving cellular energy production, which protects kidney cells from damage. HIIT improves cardiovascular health and muscle mass, preventing frailty and sarcopenia. These treatments are crucial for kidney failure patients as they address key complications and improve overall quality of life.

PAN-AMPK Activation Improves Renal Function in a Rat Model of Progressive Diabetic Nephropathy.UCP2-dependent improvement of mitochondrial dynamics protects against acute kidney injury.Albuminuria enhances NHE3 and NCC via stimulation of mitochondrial oxidative stress/angiotensin II axis.