Status:
RECRUITING
CoQ10 and Exercise for Mitochondrial Dysfunction in Advance Kidney Disease
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
University of California, Davis
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
Frailty and sarcopenia in patients with end-stage renal disease (ESRD) Patients on maintenance hemodialysis (MHD) experience frailty and sarcopenia. Approximately 73% of patients are diagnosed with fr...
Eligibility Criteria
Inclusion
- Subjects 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)
Exclusion
- 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
- Subjects 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.
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT05422534
Start Date
June 1 2023
End Date
October 1 2027
Last Update
January 2 2026
Active Locations (2)
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1
University of California Davis Health
Sacramento, California, United States, 95817
2
Vanderbilt University Medical Center-GCRC
Nashville, Tennessee, United States, 37232