Neurovascular Transduction During Exercise in Chronic Kidney Disease

This study is looking into why people with chronic kidney disease (CKD) have trouble exercising and experience high blood pressure during physical activity. Researchers want to understand if increased adrenaline or blood vessel issues are contributing factors. They will test if regular exercise on a bicycle, or taking 6R-BH4 (Kuvan) pills, or histidine and beta-alanine supplements can improve these problems. 6R-BH4 is approved for a different condition (phenylketonuria) but not currently for blood pressure or exercise capacity in CKD. You may be able to join if you are 18-75 years old and have Stage III or IV CKD, meaning your kidney function (eGFR) is between 15-59 cc/minute. The study aims to see if these interventions change how your body responds to exercise and how your blood vessels react.

Study design
This is an interventional study with a planned enrollment of 150 participants. It is not specified if the study is randomized or blinded.
What's involved
Participants will take study pills (6R-BH4 or placebo) twice daily for 12 weeks, and 1 mg of folic acid daily for 12 weeks. Some participants will exercise 3 times a week on a stationary ergometer, while others will do stretching exercises.
Compensation
Not stated in the trial record.
Follow-up
Changes in functional sympatholysis, vascular alpha 1 adrenergic responsiveness, and exaggerated pressor responses during exercise will be measured at Baseline and Week 12.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02947750

Neurovascular Transduction During Exercise in Chronic Kidney Disease

Recruiting
PHASE2Ages 18–75InterventionalSupportive care
Emory University
~150 participants
Updated 2026-05-18 on ClinicalTrials.gov
What's tested:6R-BH46R-BH4 placeboFolic acidExercise trainingStretchingHistidine and beta-alanine supplementation

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in functional sympatholysis
Measured over Baseline, Week 12
+2 more outcomes measured
Renal Insufficiency, Chronic

NCT02947750

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Atlanta VA Health Care System

    Decatur, Georgiastudy coordinator listed

    Recruiting

  • Emory University Hospital

    Atlanta, Georgiastudy coordinator listed

    Recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Joe Nocera, PhD · PRINCIPAL_INVESTIGATOR · Emory University

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

Exclusion

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
  • Change in functional sympatholysisBaseline, Week 12

    Muscle oxygenation during exercise and sympathoexcitation will be measured.

  • Change in vascular alpha 1 adrenergic responsivenessBaseline, Week 12

    Changes in vascular diameter in response to phenylephrine will be measured.

  • Change in exaggerated pressor responses during exerciseBaseline, Week 12

    Blood pressure and sympathetic responses during exercise will be measured.