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New treatment option for Chronic Kidney Disease
Official title Sympatholysis in Chronic Kidney Disease
ClinicalTrials.gov ID: NCT02411773
What this study is testing
What is Sodium Bicarbonate?
Sodium Bicarbonate is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic kidney disease.
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 what causes an increase in blood pressure during exercise (i.e. increased adrenaline levels, or decreased ability of blood vessels to dilate).
- Phase 1: an early, usually small safety study
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. Healthy volunteers may be eligible.
You may be able to join if
- Veterans with Stages III and IV Chronic Kidney Disease (CKD)
- Kidney transplant recipients with varying degrees of kidney function
- Veterans 18-75 years old, without kidney disease, as study controls
- Exercise less than 20 minutes twice per week
- Willing and able to cooperate with the protocol
You likely can't join if
- Severe CKD (estimated glomerular filtration rate (eGFR) \< 15 cc/minute)
- Metabolic alkalosis (serum bicarbonate \> 28 meq/L)
- Ongoing drug or alcohol abuse
- Diabetic neuropathy
- Any serious systemic disease that might influence survival
- Severe anemia with hemoglobin (Hbg) level \< 10 g/dL
See the full eligibility criteria
- Veterans with Stages III and IV Chronic Kidney Disease (CKD)
- Kidney transplant recipients with varying degrees of kidney function
- Veterans 18-75 years old, without kidney disease, as study controls
- Exercise less than 20 minutes twice per week
- Willing and able to cooperate with the protocol
- Severe CKD (estimated glomerular filtration rate (eGFR) \< 15 cc/minute)
- Metabolic alkalosis (serum bicarbonate \> 28 meq/L)
- Ongoing drug or alcohol abuse
- Diabetic neuropathy
- Any serious systemic disease that might influence survival
- Severe anemia with hemoglobin (Hbg) level \< 10 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 blood pressure (BP) greater than 170/100 mmHg
- Low blood pressure with BP less than 100/50 mmHg
- Pregnancy or plans to become pregnant
- Current treatment with monoamine oxidase inhibitors (MAOIs)
- Inability to exercise on a stationary bicycle
The study team makes the final eligibility decision.
Where it's taking place
- 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. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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.