Understanding exercise capacity and blood pressure response in chronic kidney disease
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease
This study is testing if a new exercise program and some supplements can help people with chronic kidney disease improve their ability to exercise and manage their blood pressure better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 3 sites (Atlanta, Georgia and 2 other locations) |
| Trial ID | NCT02947750 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the reasons behind poor exercise capacity and increased blood pressure during exercise in patients with chronic kidney disease (CKD). It will explore the effects of aerobic exercise training and the administration of 6R-BH4, a drug currently approved for phenylketonuria, along with histidine and beta-alanine supplementation. Researchers will measure vascular reactivity, muscle pH, and oxygenation during exercise to understand the underlying mechanisms. The study will include both CKD patients and control participants who do not exercise regularly.
Who should consider this trial
Good fit: Ideal candidates include individuals with Stage III or IV chronic kidney disease who do not exercise regularly.
Not a fit: Patients with severe chronic kidney disease, ongoing substance abuse, or serious systemic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve exercise capacity and cardiovascular health in patients with chronic kidney disease.
How similar studies have performed: Other studies have shown promising results in improving exercise capacity and vascular health in CKD patients through similar interventions, but the specific combination of treatments in this study is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Atlanta, Georgia and 2 other locations
- Emory University Hospital Midtown — Atlanta, Georgia, United States (Recruiting)
- Emory University Hospital — Atlanta, Georgia, United States (Recruiting)
- Atlanta VA Health Care System — Decatur, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Joe Nocera, PhD — Emory University
- Study coordinator: Jeanie Park, MD
- Email: jeanie.park@emory.edu
- Phone: 404-727-2525
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.