Actively Recruiting
Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD
Led by University of California, Davis · Updated on 2026-05-06
80
Participants Needed
2
Research Sites
172 weeks
Total Duration
On this page
Sponsors
U
University of California, Davis
Lead Sponsor
V
Vanderbilt University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Moderate-severe chronic kidney disease with eGFR less than 50 ml/min per 1.73 m2 on at least two occasions
- Metabolic acidosis with bicarbonate level below 24 on two occasions, or bicarbonate 24 or less if eGFR is 45 ml/min per 1.73 m2 or lower
- Age between 21 and 85 years old
You will not qualify if you...
- Type 1 diabetes
- Poorly controlled diabetes with HgbA1c greater than 10%
- History of persistent high potassium levels above 5.4
- History of persistent low potassium levels below 3.3
- Uncontrolled blood pressure above 170/100
- Chronic treatment with renal replacement therapy
- History of aortic dissection or severe heart valve disease
- Exercise-induced chest pain (angina)
- Uncontrolled irregular heart rhythms
- Oxygen-dependent chronic obstructive pulmonary disease
- Symptomatic claudication
- End-stage liver disease
- Mobility disability defined as inability to walk without human assistance
- Dementia or psychosis
- Inability to provide consent
- Active intravenous drug use
- Non-English speaking
- History of transplant
- Implants or metal fragments that prevent MRI measurements
- Pacemaker
- Expectation to start dialysis during the study
- Women who are breastfeeding, pregnant, or planning pregnancy
- Any condition that the investigator believes poses a risk from study participation
- For optional muscle biopsy: use of anticoagulants or certain antiplatelet drugs, platelet count below 100,000, or INR above 1.4
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of California Davis Health
Sacramento, California, United States, 95817
Actively Recruiting
2
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Not Yet Recruiting
Research Team
B
Baback Roshanravan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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