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New treatment option for End Stage Renal Disease
Official title CoQ10 and Exercise for Mitochondrial Dysfunction in Advance Kidney Disease
ClinicalTrials.gov ID: NCT05422534
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- people age 18 to 75 years
- On thrice-weekly chronic hemodialysis for at least 6 months (only applicable for patients with ESRD on maintenance hemodialysis).
- Clinically stable, adequately dialyzed (single-pool Kt/V \>1.2) thrice weekly, for at least 3 consecutive months prior to the study (only applicable...
You likely can't join if
- Body mass index \> 35 mg/kg2
- History of functional transplant less than 6 months prior to study
- Use of immunosuppressive drugs within 1 month prior to study
- Active connective tissue disease
- Acute infectious disease within 1 month prior to study
- AIDS (HIV seropositivity is not an exclusion criterion)
See the full eligibility criteria
- people age 18 to 75 years
- On thrice-weekly chronic hemodialysis for at least 6 months (only applicable for patients with ESRD on maintenance hemodialysis).
- Clinically stable, adequately dialyzed (single-pool Kt/V \>1.2) thrice weekly, for at least 3 consecutive months prior to the study (only applicable for patients with ESRD on maintenance hemodialysis)
- Body mass index \> 35 mg/kg2
- History of functional transplant less than 6 months prior to study
- Use of immunosuppressive drugs within 1 month prior to study
- Active connective tissue disease
- Acute infectious disease within 1 month prior to study
- AIDS (HIV seropositivity is not an exclusion criterion)
- Acute myocardial infarction or cerebrovascular event within 3 months
- Uncontrolled blood pressure
- New or worsening mitral regurgitation murmur
- Hypotension, bradycardia, or tachycardia
- Prolonged ongoing (greater than 20 minutes) angina at rest
- Angina at rest with transient ST changes greater than 0.05 mV on ECG
- Sustained ventricular tachycardia on ECG
- Elevated cardiac enzymes (e.g., troponin Tor I greater than 0.1mg/ml)
- Advanced liver disease, with a modified Child-Turcotte-Pugh score equal or greater than 10.
- Gastrointestinal dysfunction requiring parental nutrition
- Active malignancy excluding basal cell carcinoma of the skin
- Ejection fraction less than 30%
- Pre-dialysis potassium repeatedly higher than 5.5 mmol/L (confirmed on a repeated blood draw)
- Anticipated live donor kidney transplant
- History of poor adherence to hemodialysis or medical regimen
- Inability to provide consent
- people with cardiac pacemaker, artificial heart valve, any metallic implant, permanent tattoo, or any retained foreign metallic bodies.
- Inability to perform exercise
- Contraindication for exercise such as electrolyte abnormalities, uncontrolled arrhythmias, or pulmonary congestion.
The study team makes the final eligibility decision.
Where it's taking place
- Sacramento, California, United States
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sacramento, California, United States; Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.