Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT02947750

Neurovascular Transduction During Exercise in Chronic Kidney Disease

Led by Emory University · Updated on 2025-03-05

150

Participants Needed

3

Research Sites

482 weeks

Total Duration

On this page

Sponsors

E

Emory University

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Neurovascular Transduction During Exercise in Chronic Kidney Disease

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Stage III or IV chronic kidney disease with estimated glomerular filtration rate (eGFR) between 15 and 59 cc/minute
  • Stable kidney function with less than 30% decrease in eGFR over past 3 months
  • Exercising less than 20 minutes twice per week
  • Willing and able to follow the study protocol
  • Control participants also must exercise less than 20 minutes twice per week and be willing and able to cooperate with the study
Not Eligible

You will not qualify if you...

  • Severe chronic kidney disease with eGFR less than 15 cc/minute
  • Ongoing drug or alcohol abuse
  • Diabetic neuropathy
  • Serious systemic diseases affecting survival
  • Severe anemia with hemoglobin below 9 g/dL
  • Congestive heart failure or ejection fraction below 35%
  • Symptomatic heart disease by tests or history
  • Treatment with central alpha agonists like clonidine
  • Uncontrolled high blood pressure above 170/100 mm Hg
  • Low blood pressure below 100/50 mm Hg
  • Pregnancy or planning pregnancy
  • Current treatment with monoamine oxidase (MAO) inhibitors
  • Inability to exercise on a stationary bicycle

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

Emory University Hospital Midtown

Atlanta, Georgia, United States, 30308

Actively Recruiting

2

Emory University Hospital

Atlanta, Georgia, United States, 30322

Actively Recruiting

3

Atlanta VA Health Care System

Decatur, Georgia, United States, 30033

Actively Recruiting

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Research Team

J

Jeanie Park, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

6

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