Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Supportive Care
Participants needed
150 (estimated)
Sponsor
Emory University · Other
Who this trial is looking for
This trial is looking for people with chronic kidney disease who want to understand their exercise difficulties and high blood pressure during exercise. Participants will try regular cycling exercise and take a pill to see if it helps improve their exercise capacity.
Are You a Good Fit for This Trial?
You may be able to join if
I have chronic kidney disease stage III or IV.
I do not exercise regularly.
I am stable with my kidney function and my levels have not dropped by more than 30% in the last 3 months.
I am willing to follow the study rules.
You may not be able to join if
I have severe chronic kidney disease.
I abuse drugs or alcohol.
I have diabetic neuropathy.
I have serious health problems affecting my survival.
I have severe anemia.
I have heart failure or a serious heart condition.
I have uncontrolled high blood pressure.
I am pregnant or planning to become pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 histidin…
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.
Trial Locations
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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 Di…
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
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