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Sodium Bicarbonate for Chronic Kidney Disease and Fatigue

This study is looking at how sodium bicarbonate affects people with chronic kidney disease (CKD) who also have metabolic acidosis (when your body has too much acid) and fatigue. Researchers want to see if taking sodium bicarbonate can improve muscle energy and how your body uses insulin. You might be eligible if you are between 21 and 85 years old, have moderate-to-severe CKD (eGFR less than 50), and metabolic acidosis (bicarbonate level less than 24). The study will measure changes in your muscle's ability to use oxygen, how sensitive your body is to insulin, and your physical endurance after 16 weeks. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 80 participants. It compares sodium bicarbonate to a placebo (an inactive substance that looks like the real drug).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main measurements are taken at 16 weeks after starting the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04984226

Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD

Recruiting
PHASE2Ages 21–85InterventionalPrevention
University of California, Davis
~80 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:Sodium bicarbonateplacebo

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
muscle mitochondrial oxidative capacity by 31P MRS
Measured over 16 weeks
+5 more outcomes measured

Conditions

Chronic Kidney Diseases
Metabolic Acidosis
Fatigue
Physical Endurance
Insulin Resistance
Mitochondrial Energetics
Diabetes

Explore related trials

Chronic Kidney DiseaseDiabetes MellitusMetabolic Acidosis

Where it's being run

2 sites across 2 states
California1
Tennessee1

Study leadership

  • Baback Roshanravan, MD · PRINCIPAL_INVESTIGATOR · UC Davis
  • Jorge Gamboa, MD PhD · PRINCIPAL_INVESTIGATOR · Vanderbilt University

Who to contact

Baback Roshanravan, MD
[email protected]
530-754-0893
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • muscle mitochondrial oxidative capacity by 31P MRS16 weeks

    We will use 31P MRS to evaluate the concentration of phospho-creatine (PCr) and other phosphate-energy carrier molecules in limb muscles. After one minute of basal resting measurements, patients will be asked to perform two knee extensions every second against ankle weights 5-10% of the maximal voluntary contraction. The exercise protocol will last 60-90 seconds (a total of 60 knee extensions) followed by 6 minutes of rest. The intensity of the exercise decreases phosphocreatine (PCr) levels with minimal change in muscle pH. Spectra analysis was performed with AMARES from the jMRUI software package. Spectra are used to calculate the relative concentrations of inorganic phosphate (Pi), PCr, and ATP. PCr recovery will be measured through 6min of rest and fit with a monoexponential equation.

  • Insulin sensitivity (SI) by insulin clamp16 weeks

    Primary endpoint for the hyperinsulinemic euglycemic clamp testing will be insulin sensitivity defined as (glucose disposal rate - concentration of infused glucose)/(insulin concentration at steady state - fasting insulin concentration). Units are mg/min per microunit per milliliter.

  • total work performed on cycle ergometry VO216 weeks

    Total work will be obtained by cycle ergometry using standard protocol measuring oxygen uptake starting at 0 watts (W) at 60 rotations per minute (rpm) increasing by 25W every 2 minutes until volitional exhaustion adapting a prior protocol used in CKD patients. The primary measure will be total work completed (Joules).

  • muscle work efficiency cycle ergometry16 weeks

    joules/ml Oxygen(VO2 peak)

  • Walking endurance by 6-minute walk16 weeks

    Meters

  • FACIT-F Fatigue (PRO)16 weeks

    score on FACIT-F questionnaire