NCT04984226 Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD
| NCT ID | NCT04984226 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of California, Davis |
| Condition | Chronic Kidney Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-09-08 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2023-09-08 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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-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
Contact & Investigator
Baback Roshanravan, MD
PRINCIPAL INVESTIGATOR
UC Davis
Frequently Asked Questions
Who can join the NCT04984226 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 85 Years, studying Chronic Kidney Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04984226 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04984226 currently recruiting?
Yes, NCT04984226 is actively recruiting participants. Contact the research team at broshanr@ucdavis.edu for enrollment information.
Where is the NCT04984226 trial being conducted?
This trial is being conducted at Sacramento, United States, Nashville, United States.
Who is sponsoring the NCT04984226 clinical trial?
NCT04984226 is sponsored by University of California, Davis. The principal investigator is Baback Roshanravan, MD at UC Davis. The trial plans to enroll 80 participants.
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