Recruiting
Phase 2

Observational Study

Sponsor:

Emory University

Code:

NCT05928936

Conditions

Chronic Kidney Disease

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Sodium Bicarbonate

Exercise Training

Placebo

Study Details

Brief summary:

The goals of this project are to investigate the mechanisms and potential therapies related to exercise capacity in persons with chronic kidney disease (CKD).

Conditions

Chronic Kidney Disease

Study ID

NCT05928936

Start date

Nov 11, 2022

Status verified date

Oct, 2025

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • patients with CKD (Stages III and IV), kidney transplant recipients with varying degrees of kidney function, or persons without kidney disease as matched study controls
  • sedentary and do not regularly exercise (defined as exercising < 20 minutes twice per week)
  • CKD patients must have stable renal function (no greater than a decline of estimated glomerular filtration (eGFR) of 1 cc/min/1.73 m2 per month over the prior 6 months) and baseline serum bicarbonate 22-24 mmol/L
  • comorbid hypertension

Exclusion Criteria:

  • severe CKD (eGFR<15 cc/min)
  • metabolic alkalosis
  • current treatment with bicarbonate
  • ongoing drug or alcohol abuse
  • diabetic neuropathy, autonomic dysfunction
  • any serious disease that might influence survival
  • anemia with hemoglobin <10 g/dL
  • clinical evidence of heart failure
  • volume overload or ejection fraction below 45%
  • symptomatic heart disease by EKG, stress test, and/or history
  • treatment with central α-agonists (clonidine)
  • myocardial infarction or cerebrovascular accident within the past six months
  • uncontrolled hypertension (BP>170/100 mm Hg)
  • low BP<100/50 mm Hg
  • surgery within the past 3 months
  • pregnancy or plans to become pregnant
  • inability to exercise on a stationary bicycle
  • contraindication to temporary withdrawal of α- and β-blockers
  • peripheral arterial disease
  • class 3 obesity (BMI>40)
  • hypo- or hyperkalemia (K<3.5meq/L, K>5.0 meq/L)
  • current use of immunosuppressive medications (including but not limited to steroids, cyclophosphamide, calcineurin inhibitors, mycophenolate, biologics, methotrexate, etc)
  • arteriovenous (AV) fistula/graft
  • any contraindication to MR scanning including cardiac pacemaker, cochlear implants, neurostimulators, implanted devices with metal, any metal in the body that could pose a hazard during scanning, history of claustrophobia

Study Design

Enrollment

156 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Exercise Training plus Sodium Bicarbonate

Participants with CKD will undergo exercise training for 20-45 minutes, 3 times per week, for 12 weeks. Additionally, participants take 650-1300 mg of sodium bicarbonate twice daily.

active comparator: Exercise Training plus Placebo

Participants with CKD will undergo exercise training for 20-45 minutes, 3 times per week, for 12 weeks. Additionally, participants take placebo tablets to match 650-1300 mg of sodium bicarbonate twice daily.

no intervention: Healthy control

Baseline measurements in healthy participants without CKD will be measured and compared to participants with CKD. Healthy controls will not receive any interventions.

Interventions

Sodium Bicarbonate

Participants take 650-1300 mg of sodium bicarbonate orally twice daily. Serum bicarbonate levels are measured at baseline and then every 2-4 weeks throughout the trial. Doses will be adjusted or held to avoid metabolic alkalosis.

Exercise Training

Exercise training consists of progressive, interval-based "Spin" exercise on stationary bicycles three times per week for 12 weeks, led by a certified exercise physiologist. The duration of each session begins at 20 minutes and is increased by 1 to 2 minutes as tolerated to a goal of 45 minutes per session. Exercise intensity begins at low levels (50% of maximal heart rate reserve (HRR)) and increases by 5% every week to a goal of 75% maximal HRR. Each session includes a 5-min warm up, then an interval-based, work-out phase that includes steady up-tempo cadences, sprints, and climbs, followed by a 5-minute cool down.

Placebo

Participants take placebo pills to match 650-1300 mg of sodium bicarbonate orally twice daily.

Primary outcome measure

  • Change in Exercise Capacity [ Time Frame: Baseline, Week 12 ]

Central Contacts and Locations

Central contacts

Dana DaCosta

404-727-7762drdacos@emory.edu

Jeanie Park, MD

404-321-6111

Locations

Emory Clinic

Recruiting

Atlanta, Georgia, United States, 30322

Atlanta VA Medical Center

Recruiting

Decatur, Georgia, United States, 30033

More Information

Sponsor

Emory University

Last update posted

Oct 21, 2025

Last verified

Oct, 2025

Keywords

  • Exercise training
  • Sodium bicarbonate
  • Exercise pressor reflex

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Emory University on 2025-10-21.