NCT04984226RecruitingPhase 2
Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD
Randomized Cross-over Trial of Sodium Bicarbonate on Muscle Mitochondrial Energetics and Physical Endurance in Chronic Kidney Disease and Metabolic Acidosis
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 8 Jul 2021
- Start date
- 8 Sept 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University of California, Davis
- Diseases
- Chronic kidney disease
- NCT number
- NCT04984226
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 80
- From 8 Sept 2023 to the primary completion date, 31 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Chronic treatment with renal replacement therapy
- Active use of intraveneous drugs
- Implants that prohibit MRI measurements or trauma involving metal fragments
- Drugs- anticoagulants or antiplatelets:
- Anticoagulants, any 1 (coumadin, rivaroxaban, apixaban, dabigatran, edoxaban)
- Antiplatelets, any 2 (aspirin, cilostazol, clopidogrel, dipyridamole, prasugrel, ticragrelor, ticlopidine, vorapaxar)
Other illness
- Type 1 diabetes
- Poorly controlled diabetes (HgbA1c\>10%)
- History of persistent hyperkalemia (K\>5.4)
- History of persistent hypokalemia (K\<3.3)
- History of aortic dissection or severe valvular heart disease
- Exercise induced angina
- Uncontrolled cardiac dysrhythmia
- Oxygen dependent chronic obstructive pulmonary disease (COPD)
- End stage liver disease
- Dementia or psychosis
- History of transplant
- Any condition which in the judgement of the clinical investigator places the participant at risk from participation in the study.
Lab values
- Platelet count \<100,000
- International normalized ratio (INR)\>1.4
Other
- Uncontrolled blood pressure (\>170/100)
- Symptomatic claudication
- Mobility disability defined as inability to walk without human assistance
- Patients who cannot consent
- Non-english speaking
- Pacemaker
- Expectation to start dialysis during the course of study.
- Women who are breastfeeding, pregnant, or are wanting to become pregnant
Who the study is looking for
- 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
Age in the registry: 21 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Not yet recruiting |
| University of California Davis Health Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.