Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
21 – 85
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
80 (estimated)
Sponsor
University of California, Davis · Other
Who this trial is looking for
This trial is looking for people with chronic kidney disease and metabolic acidosis to study how sodium bicarbonate affects muscle health and physical endurance. Participants will be monitored while receiving treatment to understand the impact on their condition.
I have metabolic acidosis with low bicarbonate levels.
I am between 21 and 85 years old.
You may not be able to join if
I have type 1 diabetes.
I have poorly controlled diabetes.
I have uncontrolled high blood pressure.
I have a history of kidney treatments like dialysis.
I have severe heart disease or aortic dissection.
I cannot walk without assistance.
I have dementia or psychosis.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 metabol…
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.
Trial Locations
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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…
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
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