Trial of Nicotinamide Riboside and Co-enzyme Q10 in Chronic Kidney Disease
Condition: Chronic Kidney Disease; Sarcopenia; Frailty
MeSH terms: Sarcopenia; Kidney Diseases; Renal Insufficiency, Chronic; Frailty
Intervention: CoQ10; Nicotinamide riboside; Placebo
Intervention description: CoQ10 tablet; NR tablet; Sugar pill designed to mimic coQ10 and NR
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids; Coenzyme Q10
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, placebo-controlled, cross-over trial
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 26.0
Sex: All
Minimum age: 30 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: Mitochondria; Antioxidants; CoQ10; Nicotinamide riboside; Ergometry; Fatigue; Aerobic capacity

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 <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)