Actively Recruiting

Phase 2
Age: 21Years - 85Years
All Genders
NCT04984226

Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD

Led by University of California, Davis · Updated on 2026-05-06

80

Participants Needed

2

Research Sites

172 weeks

Total Duration

On this page

Sponsors

U

University of California, Davis

Lead Sponsor

V

Vanderbilt University Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD

Who Can Participate

Age: 21Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Moderate-severe chronic kidney disease with eGFR less than 50 ml/min per 1.73 m2 on at least two occasions
  • Metabolic acidosis with bicarbonate level below 24 on two occasions, or bicarbonate 24 or less if eGFR is 45 ml/min per 1.73 m2 or lower
  • Age between 21 and 85 years old
Not Eligible

You will not qualify if you...

  • Type 1 diabetes
  • Poorly controlled diabetes with HgbA1c greater than 10%
  • History of persistent high potassium levels above 5.4
  • History of persistent low potassium levels below 3.3
  • Uncontrolled blood pressure above 170/100
  • Chronic treatment with renal replacement therapy
  • History of aortic dissection or severe heart valve disease
  • Exercise-induced chest pain (angina)
  • Uncontrolled irregular heart rhythms
  • Oxygen-dependent chronic obstructive pulmonary disease
  • Symptomatic claudication
  • End-stage liver disease
  • Mobility disability defined as inability to walk without human assistance
  • Dementia or psychosis
  • Inability to provide consent
  • Active intravenous drug use
  • Non-English speaking
  • History of transplant
  • Implants or metal fragments that prevent MRI measurements
  • Pacemaker
  • Expectation to start dialysis during the study
  • Women who are breastfeeding, pregnant, or planning pregnancy
  • Any condition that the investigator believes poses a risk from study participation
  • For optional muscle biopsy: use of anticoagulants or certain antiplatelet drugs, platelet count below 100,000, or INR above 1.4

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

University of California Davis Health

Sacramento, California, United States, 95817

Actively Recruiting

2

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Not Yet Recruiting

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Research Team

B

Baback Roshanravan, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

2

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Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD | DecenTrialz