NCT02947750RecruitingPhase 2
Neurovascular Transduction During Exercise in Chronic Kidney Disease
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease
Source: ClinicalTrials.gov · Last updated 18 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 17 Oct 2016
- Start date
- Oct 2016
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- Emory University
- NCT number
- NCT02947750
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 150
- From Oct 2016 to the primary completion date, 30 Apr 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- ongoing drug or alcohol abuse
- symptomatic heart disease determined by prior electrocardiogram, stress test, and/or history
- treatment with central alpha agonists (clonidine)
- current treatment with monoamine oxidase (MAO) inhibitors
Other illness
- any serious systemic disease that might influence survival
- uncontrolled hypertension with BP greater than 170/100 mm Hg
Lab values
- severe CKD (eGFR\<15 cc/minute)
- severe anemia with hgb level \<9 g/dL
- clinical evidence of congestive heart failure or ejection fraction below 35%
Other
- diabetic neuropathy
- low blood pressure with BP less than 100/50
- pregnancy or plans to become pregnant
- inability to exercise on a stationary bicycle
Who the study is looking for
- 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
- Does not exercise regularly (defined as exercising less than 20 minutes twice per week)
- Willing and able to cooperate with the study protocol
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University Hospital Midtown Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Emory University Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Atlanta VA Health Care System Coordinator of this site? Confirm its status | Decatur | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.