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Recruiting Phase 2 NCT04984226

Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD

Trial Parameters

Condition Chronic Kidney Diseases
Sponsor University of California, Davis
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 80
Sex ALL
Min Age 21 Years
Max Age 85 Years
Start Date 2023-09-08
Completion 2025-12-31
Interventions
Sodium bicarbonateplacebo

Brief Summary

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.

Eligibility 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-eng

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