Neurovascular Transduction During Exercise in Chronic Kidney Disease (NCT02947750) | Clinical Trial Compass
RecruitingPhase 2
Neurovascular Transduction During Exercise in Chronic Kidney Disease
United States150 participantsStarted 2016-10
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in functional sympatholysis
Timeframe: Baseline, Week 12
2
Change in vascular alpha 1 adrenergic responsiveness
Timeframe: Baseline, Week 12
3
Change in exaggerated pressor responses during exercise