Chronic Kidney Disease Clinical Trial
— CoNROfficial title:
Cross-over Randomized Controlled Trial of Coenzyme Q10 or Nicotinamide Riboside in Chronic Kidney Disease
Verified date | December 2022 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Chronic kidney disease is associated with the loss of skeletal muscle mass and function. This process detrimentally impacts mobility, functional independence, and quality of life. Mounting evidence suggests that chronic kidney disease impairs skeletal muscle functioning by injuring mitochondria, the central energy producing units of cells. Potential treatment options to restore mitochondrial function include aerobic and weight bearing exercise and medications that directly improve mitochondrial energetics. Unfortunately, exercise programs may be difficult to implement in people who have chronic diseases, such as kidney disease.. Coenzyme Q10 (coQ10) and nicotinamide riboside (NR) are naturally occurring supplements that can directly improve mitochondrial efficiency. Both compounds help mitochondria produce more energy while generating less waste. The primary purpose of this study is to test whether coQ10 and NR can improve muscle function among people with chronic kidney disease. What we learn in this study may help us better understand the mechanisms of skeletal muscle impairment among people with kidney disease and ultimately improve their ability to be active and independent.
Status | Completed |
Enrollment | 26 |
Est. completion date | April 26, 2021 |
Est. primary completion date | April 26, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 79 Years |
Eligibility | Inclusion Criteria: - Chronic kidney disease, defined in this study as an estimated glomerular filtration rate (eGFR) of <50ml/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration equation Exclusion Criteria: - 6-minute walking distance >500meters - Pregnancy - Receiving renal replacement therapy (dialysis or kidney transplantation) - Expectation to start dialysis within 6 months - Insulin dependent diabetes mellitus - Severe anemia: hemoglobin <8 g/dL - Hyperkalemia: K >5.7 mEq/L - Weight >300 lbs - HIV - End stage liver disease with cirrhosis - Oxygen-dependent Chronic Obstructive Pulmonary Disease (COPD) - Unable to walk unassisted from room to room in own house - Institutionalization, or inability to consent - Use of immunosuppressive medications (i.e. steroids, calcineurin inhibitors) - Malignancy requiring active treatment or currently under surveillance (at the discretion of the investigator) - Cardiac pacemaker - Current participation in another interventional trial - Non-English speaking - Hospitalization for heart attack, stroke, or unstable cardiac chest pain within the previous 3 months (e.g. myocardial infarction, unstable angina, cerebrovascular accident) - Any medical condition that the investigator feels would prevent the participant from safely completing the exercise-based outcome measurements. - Baseline systolic blood pressure >170 or diastolic blood pressure >100 - Persistent or permanent uncontrolled arrhythmia (at the discretion of the investigator) |
Country | Name | City | State |
---|---|---|---|
United States | University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximal Aerobic Capacity- CoQ10 | The maximal aerobic capacity (oxygen uptake mL/min/kg body weight) during cycle ergometry at the end of each treatment period. | 6 weeks | |
Primary | Work Efficiency | The work efficiency (oxygen uptake mL/min/kg body weight at a specified constant of 60 watts work rate for 3 minutes) during cycle ergometry at the end of each treatment period. This is reported as the work performed at 60 watts divided by the energy expended at 0 watts times 100, and reported on the percent scale.. | 6 weeks |
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