Chronic Kidney DiseasePhase 1Sym-CKDNCT02411773
Sympatholysis in Chronic Kidney Disease
A Phase 1 study testing Sodium Bicarbonate and Exercise Training in people with Chronic Kidney Disease, run by Emory University at 1 site in United States.
Trial summary
The purpose of this study is to find out why patients with chronic kidney disease (CKD) have poor exercise capacity and what causes an increase in blood pressure during exercise (i.e. increased adrenaline levels, or decreased ability of blood vessels to dilate). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- 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
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2015to Jun 2027
- Phase
- Phase 1
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Veterans with Stages III and IV Chronic Kidney Disease (CKD)
- Kidney transplant recipients with varying degrees of kidney function
- Veterans 18-75 years old, without kidney disease, as study controls
- Exercise less than 20 minutes twice per week
- Willing and able to cooperate with the protocol
Who cannot join
- Severe CKD (estimated glomerular filtration rate (eGFR) < 15 cc/minute)
- Metabolic alkalosis (serum bicarbonate > 28 meq/L)
- Ongoing drug or alcohol abuse
- Diabetic neuropathy
- Any serious systemic disease that might influence survival
- Severe anemia with hemoglobin (Hbg) level < 10 g/dL
Show all 14Show fewer
- Clinical evidence of congestive heart failure or ejection fraction below 35%
- Symptomatic heart disease determined by prior electrocardiogram, stress test, and/or history
- Treatment with central alpha agonists (clonidine)
- Uncontrolled hypertension with blood pressure (BP) greater than 170/100 mmHg
- Low blood pressure with BP less than 100/50 mmHg
- Pregnancy or plans to become pregnant
- Current treatment with monoamine oxidase inhibitors (MAOIs)
- Inability to exercise on a stationary bicycle
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jeanie Park, MD contact
United States1 site, 1 recruiting
- Recruiting
Atlanta VA Medical Center
Decatur, Georgia, 30033
Dana DaCosta, 404-727-7762, drdacos@emory.edu
Jeanie Park, MD
About this study
Official title: Functional Sympatholysis and Exercise Intolerance in Chronic Kidney Disease
The purpose of this study is to find out why patients with chronic kidney disease (CKD) have poor exercise capacity and what causes an increase in blood pressure during exercise (i.e. increased adrenaline levels, or decreased ability of blood vessels to dilate).
Read the detailed description
Patients with chronic kidney disease (CKD) suffer from exercise intolerance and poor physical capacity which contributes to increased cardiovascular risk in this patient population. Prior studies have shown that CKD patients have an exaggerated increase in blood pressure (BP) during both static and rhythmic exercise. Such abnormal hemodynamic responses to exercise can contribute to poor physical capacity and abnormal muscle blood flow during exercise in these patients. The goals of this project are to investigate the mechanisms and potential therapies targeting the abnormal hemodynamic response during exercise in CKD by examining the roles of impaired vasodilation, and exaggerated vasoconstriction.
- Conditions
- Chronic Kidney Disease
- Being tested
- Sodium Bicarbonate, Placebo, Exercise Training, Control to Exercise (Stretching)
- 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
Sodium bicarbonate tablet is 650 mg for one tablet. Oral sodium bicarbonate will be given out as 1300mg-2600mg (2-4 pills) prior to each exercise or stretching session. Serum bicarbonate measurements will be monitored throughout the study (at 2 weeks, then every 2-4 weeks thereafter), and bicarbonate dosages will be adjusted to avoid metabolic alkalosis (serum bicarbonate > 30).
PlaceboDrug
2-4 placebo pills will be given out prior to each exercise or stretching session.
Exercise TrainingBehavioural
Exercise training consists of riding a stationary bicycle for 20-45 minutes, 3 times per week, supervised by trained exercise specialists, for 6-12 weeks. The exercise program will follow the guidelines provided by the American College of Sports Medicine (ACSM) for optimizing cardiovascular fitness. Exercise intensity will begin at low levels (50 percent of resting heart rate) and increase to no greater than 80 percent of resting heart rate. Exercise time will progress, depending on subject's progress, from 20 minutes per session at first, to a maximum of 45 minutes. Trained staff members will give instructions throughout each exercise session. Before beginning each exercise session, subjects will be instructed on a warm-up focusing on preparing the legs for activity.
Control to Exercise (Stretching)Behavioural
Stretching exercise will consist of muscle stretching and toning for 20-45 minutes, 3 times per week, supervised by trained exercise specialists, for 6-12 weeks. Trained staff members will guide subjects with the stretching exercises, and activities are designed to increase flexibility and range of motion. Before beginning each stretching exercise session, subjects will be instructed to warm-up.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Training plus Sodium Bicarbonate | Active comparator | Subjects with CKD will undergo exercise training on a stationary bicycle for 20-45 minutes, 3 times per week, for 6-12 weeks. Additionally, subjects will take 1300-2600 mg (2-4 pills) of sodium bicarbonate prior to each exercise session three times a week. Receives: Drug: Sodium Bicarbonate; Behavioral: Exercise Training |
| Exercise Training plus Placebo | Active comparator | Subjects with CKD will undergo exercise training on a stationary bicycle,for 20-45 minutes, 3 times per week, for 6-12 weeks. Additionally, subjects will take 2-4 placebo tablets prior to each exercise session three times a week. Receives: Drug: Placebo; Behavioral: Exercise Training |
| Control to Exercise (Stretching) plus Sodium Bicarbonate | Active comparator | Subjects with CKD will undergo progressive whole body stretching and toning exercises 3 times a week for 20-45 minutes for 6-12 weeks. Additionally, subjects will take 1300-2600 mg (2-4 pills) of sodium bicarbonate prior to each stretching session three times a week. Receives: Drug: Sodium Bicarbonate; Behavioral: Control to Exercise (Stretching) |
| Control to Exercise (Stretching) plus Placebo | Placebo comparator | Subjects with CKD will undergo progressive whole body stretching and toning exercises 3 times a week for 20-45 minutes for 6-12 weeks. Additionally, subjects will take 2-4 placebo tablets prior to each exercise session three times a week. Receives: Drug: Placebo; Behavioral: Control to Exercise (Stretching) |
| Healthy Control | No intervention | Healthy subjects without CKD will not receive any interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle oxygenation after exercise/stretching training
Near-infrared spectroscopy (NIRS) will measure and record tissue oxyhemoglobin, deoxyhemoglobin, and total hemoglobin.
Measured: Baseline, Week 12
Change in muscle interstitial pH after exercise/stretching training
Near-infrared spectroscopy (NIRS) will give an estimation of the pH levels within the muscle interstitial space. Muscle interstitial pH markedly decreases during exercise, and is often lower than blood pH with a larger intracellular to interstitial pH gradient. CKD patients may have less ability to buffer pH changes in the interstitial space during exercise. Bicarbonate supplementation may improve muscle interstitial buffering capacity during exercise, and prevent exaggerated reductions in muscle interstitial pH during exercise.
Measured: Baseline, Week 12
Change in venoconstriction after exercise/stretching training
Dorsal hand vein model will be used to assess vascular alpha-1 adrenergic responsiveness by measuring the degree of venous constriction in response to varying dosages of local phenylephrine (PE) infusion.
Measured: Baseline, Week 12
Secondary outcomes (3)
Change in Functional Sympatholysis
Functional sympatholysis is determined by measuring the change in forearm oxygenation via near infrared spectroscopy (NIRS), and forearm blood flow and conductance using ultrasound, during sympathetic activation induced by lower body negative pressure (LBNP), at rest and during handgrip exercise. NIRS measures and records tissue oxyhemoglobin, deoxyhemoglobin, and total hemoglobin.
Measured: Baseline, 30 minutes
Change in muscle interstitial pH after handgrip exercise
Near-infrared spectroscopy (NIRS) will give an estimation of the pH levels within the muscle interstitial space. Muscle interstitial pH markedly decreases during exercise, and is often lower than blood pH with a larger intracellular to interstitial pH gradient. CKD patients may have less ability to buffer pH changes in the interstitial space during exercise. Bicarbonate supplementation may improve muscle interstitial buffering capacity during exercise, and prevent exaggerated reductions in muscle interstitial pH during exercise.
Measured: Baseline, 30 minutes
Change in Venoconstriction after Phenylephrine
Vascular function is measured as venoconstriction after administration of phenylephrine. Dorsal hand vein model will be used to assess vascular alpha-1 adrenergic responsiveness by measuring the degree of venous constriction in response to varying dosages of local phenylephrine (PE) infusion.
Measured: Baseline, 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study start11 Jun 2015
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeanie Park, Emory University
- Investigators
- Jeanie Park, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411773
- Sponsor's protocol ID
- IRB00078214
- Other IDs
- 2025P011323
- Acronym
- Sym-CKD
- Status last verified
- May 2026
- First submitted
- 3 Apr 2015
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Sympatholysis and Exercise Intolerance in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02411773
- Acronym / sponsor ID
- Sym-CKD / IRB00078214
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 11 Jun 2015 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 8 Apr 2015 (estimated)
- 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 purpose of this study is to find out why patients with chronic kidney disease (CKD) have poor exercise capacity and what causes an increase in blood pressure during exercise (i.e. increased adrenaline levels, or decreased ability of blood vessels to dilate).
Detailed description
Patients with chronic kidney disease (CKD) suffer from exercise intolerance and poor physical capacity which contributes to increased cardiovascular risk in this patient population. Prior studies have shown that CKD patients have an exaggerated increase in blood pressure (BP) during both static and rhythmic exercise. Such abnormal hemodynamic responses to exercise can contribute to poor physical capacity and abnormal muscle blood flow during exercise in these patients. The goals of this project are to investigate the mechanisms and potential therapies targeting the abnormal hemodynamic response during exercise in CKD by examining the roles of impaired vasodilation, and exaggerated vasoconstriction.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Exercise Training plus Sodium Bicarbonate | Active comparator | Drug: Sodium Bicarbonate, Behavioral: Exercise TrainingSubjects with CKD will undergo exercise training on a stationary bicycle for 20-45 minutes, 3 times per week, for 6-12 weeks. Additionally, subjects will take 1300-2600 mg (2-4 pills) of sodium bicarbonate prior to each exercise session three times a week. |
| Exercise Training plus Placebo | Active comparator | Drug: Placebo, Behavioral: Exercise TrainingSubjects with CKD will undergo exercise training on a stationary bicycle,for 20-45 minutes, 3 times per week, for 6-12 weeks. Additionally, subjects will take 2-4 placebo tablets prior to each exercise session three times a week. |
| Control to Exercise (Stretching) plus Sodium Bicarbonate | Active comparator | Drug: Sodium Bicarbonate, Behavioral: Control to Exercise (Stretching)Subjects with CKD will undergo progressive whole body stretching and toning exercises 3 times a week for 20-45 minutes for 6-12 weeks. Additionally, subjects will take 1300-2600 mg (2-4 pills) of sodium bicarbonate prior to each stretching session three times a week. |
| Control to Exercise (Stretching) plus Placebo | Placebo comparator | Drug: Placebo, Behavioral: Control to Exercise (Stretching)Subjects with CKD will undergo progressive whole body stretching and toning exercises 3 times a week for 20-45 minutes for 6-12 weeks. Additionally, subjects will take 2-4 placebo tablets prior to each exercise session three times a week. |
| Healthy Control | No intervention | –Healthy subjects without CKD will not receive any interventions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Veterans with Stages III and IV Chronic Kidney Disease (CKD)
- Kidney transplant recipients with varying degrees of kidney function
- Veterans 18-75 years old, without kidney disease, as study controls
- Exercise less than 20 minutes twice per week
- Willing and able to cooperate with the protocol
Key exclusion criteria (14 listed)
- Severe CKD (estimated glomerular filtration rate (eGFR) < 15 cc/minute)
- Metabolic alkalosis (serum bicarbonate > 28 meq/L)
- Ongoing drug or alcohol abuse
- Diabetic neuropathy
- Any serious systemic disease that might influence survival
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 BicarbonateSodium bicarbonate tablet is 650 mg for one tablet. Oral sodium bicarbonate will be given out as 1300mg-2600mg (2-4 pills) prior to each exercise or stretching session. Serum bicarbonate measurements will be monitored throughout the study (at 2 weeks, then every 2-4 weeks thereafter), and bicarbonate dosages will be adjusted to avoid metabolic alkalosis (serum bicarbonate > 30). | Drug | Control to Exercise (Stretching) plus Sodium Bicarbonate, Exercise Training plus Sodium Bicarbonate |
| Placebo2-4 placebo pills will be given out prior to each exercise or stretching session. | Drug | Control to Exercise (Stretching) plus Placebo, Exercise Training plus Placebo |
| Exercise TrainingExercise training consists of riding a stationary bicycle for 20-45 minutes, 3 times per week, supervised by trained exercise specialists, for 6-12 weeks. The exercise program will follow the guidelines provided by the American College of Sports Medicine (ACSM) for optimizing cardiovascular fitness. Exercise intensity will begin at low levels (50 percent of resting heart rate) and increase to no greater than 80 percent of resting heart rate. Exercise time will progress, depending on subject's progress, from 20 minutes per session at first, to a maximum of 45 minutes. Trained staff members will give instructions throughout each exercise session. Before beginning each exercise session, subjects will be instructed on a warm-up focusing on preparing the legs for activity. | Behavioural | Exercise Training plus Placebo, Exercise Training plus Sodium Bicarbonate |
| Control to Exercise (Stretching)Stretching exercise will consist of muscle stretching and toning for 20-45 minutes, 3 times per week, supervised by trained exercise specialists, for 6-12 weeks. Trained staff members will guide subjects with the stretching exercises, and activities are designed to increase flexibility and range of motion. Before beginning each stretching exercise session, subjects will be instructed to warm-up. | Behavioural | Control to Exercise (Stretching) plus Placebo, Control to Exercise (Stretching) plus Sodium Bicarbonate |
Primary outcome
Change in muscle oxygenation after exercise/stretching training
Time frame: Baseline, Week 12
Near-infrared spectroscopy (NIRS) will measure and record tissue oxyhemoglobin, deoxyhemoglobin, and total hemoglobin.
Change in muscle interstitial pH after exercise/stretching training
Time frame: Baseline, Week 12
Near-infrared spectroscopy (NIRS) will give an estimation of the pH levels within the muscle interstitial space. Muscle interstitial pH markedly decreases during exercise, and is often lower than blood pH with a larger intracellular to interstitial pH gradient. CKD patients may have less ability to buffer pH changes in the interstitial space during exercise. Bicarbonate supplementation may improve muscle interstitial buffering capacity during exercise, and prevent exaggerated reductions in muscle interstitial pH during exercise.
Change in venoconstriction after exercise/stretching training
Time frame: Baseline, Week 12
Dorsal hand vein model will be used to assess vascular alpha-1 adrenergic responsiveness by measuring the degree of venous constriction in response to varying dosages of local phenylephrine (PE) infusion.
3 secondary outcomes
Change in Functional Sympatholysis
Time frame: Baseline, 30 minutes
Change in muscle interstitial pH after handgrip exercise
Time frame: Baseline, 30 minutes
Change in Venoconstriction after Phenylephrine
Time frame: Baseline, 30 minutes
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 18 May 2026.
- Individual participant dataSharing planned: No
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sodium Bicarbonate and Exercise Training in people with Chronic Kidney Disease, run by Emory University at 1 site 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 5 inclusion and 14 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 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 muscle oxygenation after exercise/stretching training (time frame: Baseline, Week 12). The study lists 3 primary outcomes in all. 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 18 May 2026.