Health Trials

Neurovascular Transduction During Exercise in Chronic Kidney Disease

ConditionRenal Insufficiency, Chronic
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEmory University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

severe CKD (eGFR<15 cc/minute)

ongoing drug or alcohol abuse

diabetic neuropathy

any serious systemic disease that might influence survival

Trial design

Treatments tested in this trial

  • 6R-BH4
  • 6R-BH4 placebo
  • Folic acid
  • Exercise training
  • Stretching
  • Histidine and beta-alanine supplementation
  • Histidine and beta-alanine placebo

Treatment groups

150 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators

Emory University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov