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Neurovascular Transduction During Exercise in Chronic Kidney Disease

Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at why people with chronic kidney disease have trouble exercising and why their blood pressure rises during exercise. It tests whether regular bike exercise, 6R-BH4 (Kuvan) pills, or histidine and beta-alanine supplements help. It includes people with stage III or IV kidney disease and a comparison group; Kuvan is not FDA-approved for blood pressure or exercise problems in people with kidney disease.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Kidney disease group: Have stage III or IV chronic kidney disease, with an eGFR of 15–59. This test measures how well the kidneys filter blood.
  • Kidney disease group: Kidney function has not dropped by more than 30% in the past 3 months.
  • Both groups: Do not exercise regularly, defined as exercising less than 20 minutes twice a week.
  • Both groups: Are willing and able to follow the study plan.

Who can't join

  • Severe kidney disease, with an eGFR below 15.
  • Ongoing drug or alcohol abuse.
  • Nerve damage caused by diabetes, or a serious illness that could affect survival.
  • Severe anemia, or too few healthy red blood cells, with hemoglobin below 9 g/dL.
  • Heart failure, a heart pumping level below 35%, or heart disease that causes symptoms.
  • Blood pressure above 170/100 or below 100/50.
  • Taking central alpha agonist medicines, such as clonidine, or monoamine oxidase (MAO) inhibitors.
  • Pregnant, planning to become pregnant, or unable to exercise on a stationary bike.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (3)

GA