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New treatment option for Renal Insufficiency, Chronic
Official title Neurovascular Transduction During Exercise in Chronic Kidney Disease
ClinicalTrials.gov ID: NCT02947750
What this study is testing
What is 6R-BH4?
6R-BH4 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for renal insufficiency, chronic.
Also referred to as Tetrahydrobiopterin, Kuvan.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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 for Control Study Participants:
You likely can't join if
- 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%
See the full eligibility 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...
- 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 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Decatur, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Decatur, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.