Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD
Skeletal muscle metabolic health is critical for mobility and an underrecognized target of metabolic acidosis in chronic kidney disease. Impaired muscle mitochondrial metabolism underlies poor physical endurance increasing the risk of mobility disability. The proposed project will use precise in vivo tools to study the pathophysiology of poor physical endurance in a clinical trial treating metabolic acidosis among persons living with chronic kidney disease.
Conditions:
🦠 Chronic Kidney Diseases 🦠 Metabolic Acidosis 🦠 Fatigue 🦠 Physical Endurance 🦠 Insulin Resistance 🦠 Mitochondrial Energetics 🦠 Diabetes
🗓️ Study Start (Actual) 8 September 2023
🗓️ Primary Completion (Estimated) 31 December 2025
✅ Study Completion (Estimated) 30 July 2026
👥 Enrollment (Estimated) 80
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Sacramento, California, United States
📍 Nashville, Tennessee, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Moderate-severe CKD determined by eGFR \<50ml/min per 1.73m2 by CKD EPI equation on at least 2 consecutive occasions.
    • * Metabolic acidosis defined as bicarbonate level\<24 on two consecutive occasions. Bicarbonate level of 24 or less allowed if eGFR\<=45ml/min per 1.73m2
    • * Age 21 to 85 years old

    Exclusion Criteria:

    • * Type 2 diabetes managed with insulin treatment
    • * Poorly controlled diabetes (HgbA1c\>10%)
    • * History of persistent hyperkalemia (K\>5.4)
    • * Chronic treatment with renal replacement therapy
    • * History of aortic dissection or severe valvular heart disease
    • * Exercise induced angina
    • * Uncontrolled cardiac dysrhythmia
    • * Oxygen dependent COPD
    • * Symptomatic claudication
    • * End stage liver disease
    • * Mobility disability defined as inability to walk without human assistance
    • * Dementia or psychosis
    • * Patients who cannot consent
    • * Active use of IV drugs
    • * Non-english speaking
    • * History of transplant
    • * Implants that prohibit MRI measurements or trauma involving metal fragments
    • * Pacemaker
    • * Expectation to start dialysis during the course of study.
    • * Any condition which in the judgement of the clinical investigator places the participant at risk from participation in the study.
Ages Eligible for Study: 21 Years to 85 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 8 July 2021
  • First Submitted that Met QC Criteria 20 July 2021
  • First Posted 30 July 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 4 July 2024
  • Last Update Posted 8 July 2024
  • Last Verified July 2024