Using sodium bicarbonate to improve muscle health in chronic kidney disease
Randomized Cross-over Trial of Sodium Bicarbonate on Muscle Mitochondrial Energetics and Physical Endurance in Chronic Kidney Disease and Metabolic Acidosis
This study is testing if sodium bicarbonate can help improve muscle health and endurance in people with chronic kidney disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 21 Years to 85 Years |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Locations | 2 sites (Sacramento, California and 1 other locations) |
| Trial ID | NCT04984226 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of sodium bicarbonate on muscle mitochondrial function and endurance in individuals with chronic kidney disease (CKD) and metabolic acidosis. The study aims to understand how metabolic acidosis impacts muscle health and physical endurance, which are critical for maintaining mobility in CKD patients. Participants will receive either sodium bicarbonate or a placebo, and their muscle metabolism will be assessed using advanced imaging techniques. The goal is to determine if sodium bicarbonate can enhance muscle mitochondrial function and improve overall physical performance.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 21 to 85 with moderate to severe chronic kidney disease and metabolic acidosis.
Not a fit: Patients with uncontrolled diabetes, severe cardiovascular issues, or those requiring renal replacement therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve physical endurance and quality of life for patients with chronic kidney disease.
How similar studies have performed: While the approach of using sodium bicarbonate in this context is novel, previous studies have indicated potential benefits of addressing metabolic acidosis in chronic kidney disease.
Eligibility criteria
Show full inclusion / exclusion criteria
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 1 diabetes * Poorly controlled diabetes (HgbA1c\>10%) * History of persistent hyperkalemia (K\>5.4) * History of persistent hypokalemia (K\<3.3) * Uncontrolled blood pressure (\>170/100) * Chronic treatment with renal replacement therapy * History of aortic dissection or severe valvular heart disease * Exercise induced angina * Uncontrolled cardiac dysrhythmia * Oxygen dependent chronic obstructive pulmonary disease (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 intraveneous 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. * Women who are breastfeeding, pregnant, or are wanting to become pregnant * Any condition which in the judgement of the clinical investigator places the participant at risk from participation in the study. Exclusion criteria for optional muscle biopsy * Drugs- anticoagulants or antiplatelets: * Anticoagulants, any 1 (coumadin, rivaroxaban, apixaban, dabigatran, edoxaban) * Antiplatelets, any 2 (aspirin, cilostazol, clopidogrel, dipyridamole, prasugrel, ticragrelor, ticlopidine, vorapaxar) * Platelet count \<100,000 * International normalized ratio (INR)\>1.4
Where this trial is running
Sacramento, California and 1 other locations
- University of California Davis Health — Sacramento, California, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Baback Roshanravan, MD — UC Davis
- Study coordinator: Baback Roshanravan, MD
- Email: broshanr@ucdavis.edu
- Phone: 530-754-0893
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.