Phase 2
N=26
Trial of Nicotinamide Riboside and Co-enzyme Q10 in Chronic Kidney Disease
Chronic Kidney Disease · Sarcopenia · Frailty
Bottom Line
View on ClinicalTrials.gov: NCT03579693 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: Maximal Aerobic Capacity- CoQ10 — 21.4; 20.7; 20.7 mL/min/kg — p=0.33
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CoQ10 (Dietary_supplement); Nicotinamide riboside (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximal Aerobic Capacity- CoQ10 |
21.4; 20.7; 20.7 | 0.33 |
| PRIMARY Work Efficiency |
33.3; 32.5; 33.1 | 0.050 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Chronic kidney disease, defined in this study as an estimated glomerular filtration rate (eGFR) of 500meters
- Pregnancy
- Receiving renal replacement therapy (dialysis or kidney transplantation)
- Expectation to start dialysis within 6 months
- Insulin dependent diabetes mellitus
- Severe anemia: hemoglobin 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)
Data sourced from ClinicalTrials.gov (NCT03579693). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.