Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial will evaluate the effect of HIIT and CoQ10 on mitochondrial function and physical performance in patients with ESRD.
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.Check my eligibility
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.See study 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 belowSelect...
I have been on dialysis 3 times a week for at least 6 months.
Select...
I am between 18 and 75 years old.
Select...
I have been on stable dialysis treatment 3 times a week for the last 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PCr recovery measured by 31 phosphorus magnetic resonance spectroscopy
Secondary outcome measures
Six minute walk test
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).
Find a Location
Who is running the clinical trial?
University of California, DavisOTHER
911 Previous Clinical Trials
4,709,427 Total Patients Enrolled
2 Trials studying Kidney Failure
827 Patients Enrolled for Kidney Failure
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,001 Total Patients Enrolled
1 Trials studying Kidney Failure
75 Patients Enrolled for Kidney Failure
Talat Ikizler, MDPrincipal InvestigatorVUMC
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have not had an infection in the last month.Your blood potassium level is consistently higher than 5.5 mmol/L before dialysis.Your heart has a specific type of abnormal fast rhythm that shows up on an ECG test.I have cancer, but it's not just skin cancer.I have an active connective tissue disease.I am expected to receive a kidney from a living donor.I have not had a heart attack or stroke in the last 3 months.I had an organ transplant less than 6 months ago.I have a new or worsening heart murmur.I do not have AIDS, but I may be HIV positive.I have chest pain at rest with specific changes in my heart's electrical activity.I have been on dialysis 3 times a week for at least 6 months.I am between 18 and 75 years old.I have been on stable dialysis treatment 3 times a week for the last 3 months.I am unable to give consent by myself.You weigh more than the recommended weight for your height.I haven't taken immunosuppressive drugs in the last month.My blood pressure is not well-managed.I cannot perform physical exercises.My liver disease is severe, with a high Child-Pugh score.I cannot exercise due to heart rhythm problems or lung issues.Your heart enzyme levels are higher than normal.Your heart's ejection fraction is less than 30%.You have a history of not following your dialysis or medication schedule.
Research Study Groups:
This trial has the following groups:- Group 1: Observational + placebo
- Group 2: Observational+ CoQ10
- Group 3: HB HIIT +placebo
- Group 4: HB HIIT + CoQ10
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do you want to be a part of this trial if you are over the age of 50?
"This trial is only seeking patients aged 18-75. There are 52 other trials for patients who fall outside of this age bracket that are currently running."
Answered by AI
Has the FDA cleared Observational+ CoQ10 for public consumption?
"There is some evidence from earlier phases of testing that suggest the Observational+ CoQ10 is effective and safe."
Answered by AI
Who meets the eligibility requirements for participating in this experiment?
"This study is seeking 156 individuals that have kidney failure and are chronologically between 18 to 75 years old."
Answered by AI
Are there any available positions for candidates in this experiment?
"Based on a review of the latest information from clinicaltrials.gov, this study is not looking for new participants at this time. The listing was first posted on 1/20/2023 and was last updated on 10/11/2022. There are 608 other trials that are actively recruiting right now."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger