Neurovascular Transduction During Exercise in Chronic Kidney Disease

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Folic Acid; Vitamin B Complex

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