What this study is
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.
What's being tested
- Sodium bicarbonate
Intervention · DRUG
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
Intervention · DRUG
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.
Study details
- Official title
- Randomized Cross-over Trial of Sodium Bicarbonate on Muscle Mitochondrial Energetics and Physical Endurance in Chronic Kidney Disease and Metabolic Acidosis
- Sponsor
- University of California, Davis
- Conditions
- Chronic Kidney Diseases · Metabolic Acidosis · Fatigue · Physical Endurance · Insulin Resistance · Mitochondrial Energetics · Diabetes
- Enrolling
- 80 people
- Starts
- 2023-09-08
- Est. completion
- 2026-12-31
- Design
- Quadruple-blind, randomized, crossover, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 21 Years – 85 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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.
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openUniversity of California Davis Health
Sacramento, California, United States
- Amanda Lopez · Contact916-734-0898aflopez@ucdavis.edu
- Erica Goude · Contact(916) 734-0384emgoude@ucdavis.edu
- Baback Roshanravan, MD MS · Principal investigator
RecruitingVanderbilt University Medical Center
Nashville, Tennessee, United States
- Delia Woods, RN · Contactdelia.woods@vumc.org
- Jorge Gamboa, MD PhD · Principal investigator
Not yet recruiting
Study team
Sponsor
University of California, Davis
Study ID 1785131
Principal investigator
Baback Roshanravan, MD
UC Davis
Principal investigator
Jorge Gamboa, MD PhD
Vanderbilt University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.