Understanding exercise capacity and blood pressure response in chronic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.