Recruiting

Phase 2

Sodium Bicarbonate & Mitochondrial EnergeticsSodium Bicarbonate and Mitochondrial Energetics in Persons With CKD

Sponsor:

UCLA

Code:

NCT04984226

Conditions

Chronic Kidney Diseases

Metabolic Acidosis

Fatigue

Physical Endurance

Insulin Resistance

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Sodium bicarbonate

placebo

Study Details

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.

Conditions

Chronic Kidney Diseases

Metabolic Acidosis

Fatigue

Physical Endurance

Insulin Resistance

Study ID

NCT04984226

Start date

Sep 8, 2023

Status verified date

May, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Sodium bicarbonate 16 weeks

Sodium bicarbonate will be dosed at 0.8meq per kilogram of ideal body weight daily (1meq is approximately 84mg). We will use the Devine formula to determine ideal body weight. Investigational Drug Services at both UC Davis and Vanderbilt will compound the sodium bicarbonate. Sodium bicarbonate 650 mg tablets will be over-encapsulated and matching placebo capsules will be prepared. Participants will be limited to a maximum of 9 capsules daily (maximum dose = 5850mg of sodium bicarbonate). Capsules will be dispensed to patients in two separate 8-week allotments. The dose will be rounded to the nearest whole capsule and depending on participant preference may be divided into portions taken twice or thrice daily. Given the high probability of interruption in sodium bicarbonate supply and availability, we may need to change brands of sodium bicarbonate intermittently.

placebo comparator: placebo 16 weeks

Microcrystalline cellulose

Interventions

Sodium bicarbonate

placebo

The placebo and filler for for sodium bicarbonate capsules will be comprised of microcrystalline cellulose. Capsule appearance for control and sodium bicarbonate will be the same.

Primary outcome measure

muscle mitochondrial oxidative capacity by 31P MRS [ Time Frame: 16 weeks ]
Insulin sensitivity (SI) by insulin clamp [ Time Frame: 16 weeks ]
total work performed on cycle ergometry VO2 [ Time Frame: 16 weeks ]
muscle work efficiency cycle ergometry [ Time Frame: 16 weeks ]
Walking endurance by 6-minute walk [ Time Frame: 16 weeks ]
FACIT-F Fatigue (PRO) [ Time Frame: 16 weeks ]

Central Contacts and Locations

Central contacts

Baback Roshanravan, MD

530-754-0893 broshanr@ucdavis.edu

Locations

University of California Davis Health

Recruiting

Sacramento, California, United States, 95817

Contacts

Amanda Lopez

916-734-0898 aflopez@ucdavis.edu

Erica Goude

(916) 734-0384 emgoude@ucdavis.edu

Principal Investigator:

Baback Roshanravan, MD MS

More Information

Sponsor

University of California, Davis

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

Metabolic acidosis
Chronic kidney disease
Insulin resistance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-05-06.