Neurovascular Transduction During Exercise in Chronic Kidney Disease
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Renal Insufficiency, Chronic
In brief
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.
Key facts
- Study ID
- NCT02947750
- Run by
- Emory University
- People needed
- 150
- Starts
- 2016-10-01
- Expected to finish
- 2027-04-30
- Last updated by the study team
- 2026-05-18
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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
Where it is running
- Emory University Hospital Midtown — Atlanta, Georgia, United States (enrolling)
- Emory University Hospital — Atlanta, Georgia, United States (enrolling)
- Atlanta VA Health Care System — Decatur, Georgia, United States (enrolling)
Full record on ClinicalTrials.gov
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