Randomized Cross-over Trial of Sodium Bicarbonate on Muscle Mitochondrial Energetics and Physical Endurance in Chronic Kidney Disease and Metabolic Acidosis

Who is this study for? Patients with Chronic Kidney Diseases, Metabolic Acidosis
What treatments are being studied? Veverimer
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University of California Davis Health
RECRUITING
Sacramento
Tennessee
Vanderbilt University Medical Center
NOT_YET_RECRUITING
Nashville
Contact Information
Primary
Baback Roshanravan, MD
broshanr@ucdavis.edu
530-754-0893
Time Frame
Start Date: 2023-09-08
Estimated Completion Date: 2026-07-30
Participants
Target number of participants: 80
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Vanderbilt University Medical Center
Leads: University of California, Davis

This content was sourced from clinicaltrials.gov