Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD

PHASE2RecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

September 8, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

July 30, 2026

Conditions
Chronic Kidney DiseasesMetabolic AcidosisFatiguePhysical EnduranceInsulin ResistanceMitochondrial EnergeticsDiabetes
Interventions
DRUG

Sodium bicarbonate

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.

DRUG

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.

Trial Locations (2)

37232

NOT_YET_RECRUITING

Vanderbilt University Medical Center, Nashville

95817

RECRUITING

University of California Davis Health, Sacramento

All Listed Sponsors
collaborator

Vanderbilt University Medical Center

OTHER

collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

University of California, Davis

OTHER