Chronic Kidney DiseasePhase 2NCT05928936
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
A Phase 2 study testing Sodium Bicarbonate and Exercise Training in people with Chronic Kidney Disease, run by Emory University at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Sodium Bicarbonate and Exercise Training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Nov 2022to 1 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jeanie Park, MD contact
United States2 sites, 2 recruiting
- Recruiting
Emory Clinic
Atlanta, Georgia, 30322
- Recruiting
Atlanta VA Medical Center
Decatur, Georgia, 30033
About this study
The goals of this project are to investigate the mechanisms and potential therapies related to exercise capacity in persons with chronic kidney disease (CKD).
Read the detailed description
Patients with chronic renal failure suffer from exercise intolerance and poor physical capacity. Both patients with end-stage renal disease (ESRD) and chronic kidney disease (CKD) not yet on dialysis have significant impairments in measures of exercise capacity including peak work capacity (PWC) and peak oxygen uptake (VO2 peak). The mechanisms underlying exercise intolerance in CKD are multifactorial and not fully understood, and the mechanistic roles of abnormal neurocirculatory and vascular responses during exercise have not been fully elucidated. Such abnormalities have been found to be an important pathogenic mechanism underlying the exercise dysfunction of other chronic conditions, yet remain largely unexplored in CKD. This translational research program will fill this gap by examining the role of abnormal neural and vascular responses in the pathogenesis of exercise dysfunction in CKD.
The normal physiologic responses to exercise include an increase in cardiac output and blood pressure (BP) that serves to meet the increased metabolic demands of skeletal muscle. The BP response is mediated by a balance between vasoconstrictive and vasodilatory forces induced during exercise. The major vasoconstrictive force is reflex activation of the sympathetic nervous system (SNS) which serves to help shunt blood to working skeletal muscle. Concomitantly, local vasodilation largely mediated by nitric oxide (NO) and adenosine triphosphate (ATP) opposes sympathetic innervation within the exercising skeletal muscle in order to preserve blood flow and conductance to the metabolically active tissues, termed functional sympatholysis (FS). Conceivably, a derangement in the balance between vasoconstriction (by overactivation of neural SNS outflow) and vasodilation (by impaired FS) could result in an exaggerated BP response during exercise, and contribute to poor exercise tolerance.
Prior studies demonstrate that patients with both ESRD and CKD have an exaggerated increase in BP during isometric and rhythmic exercise. A heightened increase in BP during exercise could contribute to exercise impairment by increasing cardiac workload against an elevated peripheral resistance and impairing muscle blood flow during exercise. Moreover, exaggerated pressor responses during exercise have been shown to correlate with an increased risk of cardiovascular (CV) disease. Therefore, understanding the pathogenesis of this augmented BP response in CKD is crucial. This study will examine the potential mechanisms underlying the exaggerated BP response in CKD patients by evaluating the balance between vasoconstrictive and vasodilatory forces induced during exercise. The researchers hypothesize that CKD patients have an impairment in FS during exercise, an augmentation in vasoconstriction mediated by augmented sympathetic nerve activation in response to greater reductions in muscle interstitial pH, and greater vascular reactivity. The final goal is to determine if interventions that improve NO bioavailability (aerobic exercise training), and improve muscle interstitial pH (sodium bicarbonate supplementation), will ameliorate the exaggerated exercise pressor response, and improve FS and sympathetic nerve activation during exercise in CKD.
The first study aim is to determine the role of muscle interstitial acidosis on the augmented exercise pressor reflex in chronic kidney disease (CKD) patients by enrolling 120 individuals with CKD and 36 controls participants without CKD. For the second aim of this study, the participants with CKD will enter a randomized, double-blinded, parallel-group, placebo-controlled trial to determine if sodium bicarbonate enhances the beneficial effects of exercise training on physical functioning in CKD patients. CKD patients will be randomized to take sodium bicarbonate with exercise training or to take a placebo with exercise training for 12 weeks.
- Conditions
- Chronic Kidney Disease
- Being tested
- Sodium Bicarbonate, Exercise Training, Placebo
- Keywords
- Exercise training, Sodium bicarbonate, Exercise pressor reflex
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium BicarbonateDrug
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 TrainingBehavioural
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.
PlaceboDrug
Participants take placebo pills to match 650-1300 mg of sodium bicarbonate orally twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Training plus Sodium Bicarbonate | Experimental | 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. Receives: Drug: Sodium Bicarbonate; Behavioral: Exercise Training |
| Exercise Training plus Placebo | Active comparator | 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. Receives: Behavioral: Exercise Training; Drug: Placebo |
| Healthy control | No intervention | Baseline measurements in healthy participants without CKD will be measured and compared to participants with CKD. Healthy controls will not receive any interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Exercise Capacity
Exercise capacity measured as VO2 peak during a maximal treadmill exercise test. Higher VO2 max indicates increased oxygen consumption and improved fitness.
Measured: Baseline, Week 12
Secondary outcomes (7)
Change in Systolic Blood Pressure
Seated resting blood pressure is measured using an automated blood pressure monitor following American Heart Association/American College of Cardiology (AHA/ACC) technique. Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 millimeters of mercury (mmHg).
Measured: Baseline, Week 12
Change in Diastolic Blood Pressure
Seated resting blood pressure will be measured using an automated blood pressure monitor following AHA/ACC technique. Diastolic blood pressure is the amount of pressure in the arteries when the heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg.
Measured: Baseline, Week 12
Change in Muscle Sympathetic Nerve Activity (MSNA)
MSNA will be measured at rest for 10 minutes using microneurography. The gold-standard method for measuring SNS activity in humans is by direct, intraneural measurements of sympathetic nerve activity via microneurography. The peroneal nerve is located with transcutaneous stimulation. A tungsten microelectrode (tip diameter 5-15um) is then inserted into the nerve, and a reference electrode is inserted 1-2 cm from the recording electrode. Nerve signals are preamplified (gain 1000), amplified (gain 50-100), filtered (700-2000 Hz), rectified, and integrated (time constant 0.1 sec) to obtain a mean voltage display of sympathetic nerve activity that is recorded. Muscle sympathetic bursts are identified by visual inspection and expressed as burst frequency (bursts per minute) and total activity (units per minute).
Measured: Baseline, Week 12
Change in Interleukin 6 (IL-6)
Plasma concentration of the inflammatory biomarker IL-6 will be assessed. IL-6 is increased during injury or illness.
Measured: Baseline, Week 12
Change in T2 relaxation of muscle water (T2water)
T2water is a biomarker of muscle inflammation and is measured during magnetic resonance imaging (MRI). T2 relaxation of muscle water (T2water) is extracted from MRI images and is measured in milliseconds (ms).
Measured: Baseline, Week 12
Change in Lean Body Mass
Lean body mass is measured using bioimpedance. Lean body mass is assessed in kilograms (kg) and is total body weight minus body fat weight.
Measured: Baseline, Week 12
Change in Exercise Pressor Reflex
The exercise pressor reflex will be measured as the change in MSNA during rhythmic handgrip exercise.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start11 Nov 2022
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jeanie Park, Emory University
- Investigators
- Jeanie Park, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928936
- Sponsor's protocol ID
- IRB00078214a
- Other IDs
- 2R01HL135183, 2025P011323
- Status last verified
- Oct 2026
- First submitted
- 25 Jun 2023
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results of this study will be available to be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
- ClinicalTrials.gov ID
- NCT05928936
- Acronym / sponsor ID
- IRB00078214a
- Conditions
- Chronic Kidney Disease
- Keywords
- Exercise training, Sodium bicarbonate, Exercise pressor reflex
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goals of this project are to investigate the mechanisms and potential therapies related to exercise capacity in persons with chronic kidney disease (CKD).
Detailed description
Patients with chronic renal failure suffer from exercise intolerance and poor physical capacity. Both patients with end-stage renal disease (ESRD) and chronic kidney disease (CKD) not yet on dialysis have significant impairments in measures of exercise capacity including peak work capacity (PWC) and peak oxygen uptake (VO2 peak). The mechanisms underlying exercise intolerance in CKD are multifactorial and not fully understood, and the mechanistic roles of abnormal neurocirculatory and vascular responses during exercise have not been fully elucidated. Such abnormalities have been found to be an important pathogenic mechanism underlying the exercise dysfunction of other chronic conditions, yet remain largely unexplored in CKD. This translational research program will fill this gap by examining the role of abnormal neural and vascular responses in the pathogenesis of exercise dysfunction in CKD.
The normal physiologic responses to exercise include an increase in cardiac output and blood pressure (BP) that serves to meet the increased metabolic demands of skeletal muscle. The BP response is mediated by a balance between vasoconstrictive and vasodilatory forces induced during exercise. The major vasoconstrictive force is reflex activation of the sympathetic nervous system (SNS) which serves to help shunt blood to working skeletal muscle. Concomitantly, local vasodilation largely mediated by nitric oxide (NO) and adenosine triphosphate (ATP) opposes sympathetic innervation within the exercising skeletal muscle in order to preserve blood flow and conductance to the metabolically active tissues, termed functional sympatholysis (FS). Conceivably, a derangement in the balance between vasoconstriction (by overactivation of neural SNS outflow) and vasodilation (by impaired FS) could result in an exaggerated BP response during exercise, and contribute to poor exercise tolerance.
Prior studies demonstrate that patients with both ESRD and CKD have an exaggerated increase in BP during isometric and rhythmic exercise. A heightened increase in BP during exercise could contribute to exercise impairment by increasing cardiac workload against an elevated peripheral resistance and impairing muscle blood flow during exercise. Moreover, exaggerated pressor responses during exercise have been shown to correlate with an increased risk of cardiovascular (CV) disease. Therefore, understanding the pathogenesis of this augmented BP response in CKD is crucial. This study will examine the potential mechanisms underlying the exaggerated BP response in CKD patients by evaluating the balance between vasoconstrictive and vasodilatory forces induced during exercise. The researchers hypothesize that CKD patients have an impairment in FS during exercise, an augmentation in vasoconstriction mediated by augmented sympathetic nerve activation in response to greater reductions in muscle interstitial pH, and greater vascular reactivity. The final goal is to determine if interventions that improve NO bioavailability (aerobic exercise training), and improve muscle interstitial pH (sodium bicarbonate supplementation), will ameliorate the exaggerated exercise pressor response, and improve FS and sympathetic nerve activation during exercise in CKD.
The first study aim is to determine the role of muscle interstitial acidosis on the augmented exercise pressor reflex in chronic kidney disease (CKD) patients by enrolling 120 individuals with CKD and 36 controls participants without CKD. For the second aim of this study, the participants with CKD will enter a randomized, double-blinded, parallel-group, placebo-controlled trial to determine if sodium bicarbonate enhances the beneficial effects of exercise training on physical functioning in CKD patients. CKD patients will be randomized to take sodium bicarbonate with exercise training or to take a placebo with exercise training for 12 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise Training plus Sodium Bicarbonate | Experimental | Drug: Sodium Bicarbonate, Behavioral: Exercise TrainingParticipants 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. |
| Exercise Training plus Placebo | Active comparator | Behavioral: Exercise Training, Drug: PlaceboParticipants 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. |
| Healthy control | No intervention | –Baseline measurements in healthy participants without CKD will be measured and compared to participants with CKD. Healthy controls will not receive any interventions. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (24 listed)
- severe CKD (eGFR<15 cc/min)
- metabolic alkalosis
- current treatment with bicarbonate
- ongoing drug or alcohol abuse
- diabetic neuropathy, autonomic dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium BicarbonateParticipants 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. | Drug | Exercise Training plus Sodium Bicarbonate |
| Exercise TrainingExercise 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. | Behavioural | Exercise Training plus Placebo, Exercise Training plus Sodium Bicarbonate |
| PlaceboParticipants take placebo pills to match 650-1300 mg of sodium bicarbonate orally twice daily. | Drug | Exercise Training plus Placebo |
Primary outcome
Change in Exercise Capacity
Time frame: Baseline, Week 12
Exercise capacity measured as VO2 peak during a maximal treadmill exercise test. Higher VO2 max indicates increased oxygen consumption and improved fitness.
7 secondary outcomes
Change in Systolic Blood Pressure
Time frame: Baseline, Week 12
Change in Diastolic Blood Pressure
Time frame: Baseline, Week 12
Change in Muscle Sympathetic Nerve Activity (MSNA)
Time frame: Baseline, Week 12
Change in Interleukin 6 (IL-6)
Time frame: Baseline, Week 12
Change in T2 relaxation of muscle water (T2water)
Time frame: Baseline, Week 12
Change in Lean Body Mass
Time frame: Baseline, Week 12
Change in Exercise Pressor Reflex
Time frame: Baseline, Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results of this study will be available to be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeanie Park, MD contact
Jeanie Park, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium Bicarbonate and Exercise Training in people with Chronic Kidney Disease, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dana DaCosta (404-727-7762, drdacos@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Exercise Capacity (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.