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Neurovascular Transduction During Exercise in Chronic Kidney Disease
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease
Who can join
Ages 18 to 75 · All sexes
Full eligibility criteria
Inclusion Criteria for Chronic Kidney Disease Patients: * Stage III or IV Chronic Kidney Disease, defined as reduction in estimated glomerular filtration rate (eGFR) to 15-59 cc/minute as calculated by the modified Modification of Diet in Renal Disease (MDRD) Study equation or the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation * Stable renal function, with no greater than a 30% reduction in eGFR over the prior 3 months * Does not exercise regularly (defined as exercising less than 20 minutes twice per week) * Willing and able to cooperate with the study protocol Inclusion Criteria for Control Study Participants: * Does not exercise regularly (defined as exercising less than 20 minutes twice per week) * Willing and able to cooperate with the study protocol Exclusion Criteria: * severe CKD (eGFR\<15 cc/minute) * ongoing drug or alcohol abuse * diabetic neuropathy * any serious systemic disease that might influence survival * severe anemia with hgb level \<9 g/dL * 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 BP greater than 170/100 mm Hg * low blood pressure with BP less than 100/50 * pregnancy or plans to become pregnant * current treatment with monoamine oxidase (MAO) inhibitors * inability to exercise on a stationary bicycle
About the study
The purpose of this study is to find out why patients with chronic kidney disease (CKD) have poor exercise capacity and to explore what causes an increase in blood pressure during exercise (i.e. increased adrenaline levels, or decreased ability of blood vessels to dilate). This study will also test whether or not regular exercise on a bicycle and/or treatment with 6R-BH4 (Kuvan) pills, or histidine and beta-alanine supplementation improves these measures during exercise. 6R-BH4 is currently FDA-approved for use in patients with certain forms of a disease called phenylketonuria, but it is not currently FDA approved for blood pressure or exercise capacity in people with CKD.
What is being tested
- 6R-BH4 (drug)
- 6R-BH4 placebo (other)
- Folic acid (dietary supplement)
- Exercise training (other)
- Stretching (other)
- Histidine and beta-alanine supplementation (dietary supplement)
Sponsor: Emory University · Participants: 150 · Started: 2016-10
Contact the study team
- Jeanie Park, MD · Phone: 404-727-2525
Official record on ClinicalTrials.gov — NCT02947750
Locations in the U.S.
| Georgia | Emory University Hospital, Atlanta Emory University Hospital Midtown, Atlanta Atlanta VA Health Care System, Decatur |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.