Using sodium bicarbonate to improve muscle health in chronic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.