Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD

Launched by UNIVERSITY OF CALIFORNIA, DAVIS · Jul 20, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at how sodium bicarbonate, a common substance, may help improve muscle health in people with chronic kidney disease (CKD). CKD can lead to a condition called metabolic acidosis, which affects how well our muscles work and can make it harder to stay active. By treating metabolic acidosis, the researchers hope to find out if it can enhance physical endurance and overall mobility in individuals living with CKD.

To participate in the trial, you need to be between the ages of 21 and 85 and have moderate to severe CKD, which is measured by specific kidney function tests. You also need to have metabolic acidosis, shown by low bicarbonate levels in your blood. However, there are some conditions that would exclude you from participating, such as having uncontrolled diabetes or certain heart problems. If you join the study, you'll receive treatment and be closely monitored to see how it affects your muscle health and physical activity. This trial is currently recruiting participants, and it's a chance to contribute to important research that could improve the care for people with chronic kidney disease.

Gender

ALL

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-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