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New treatment option for Chronic Kidney Disease
Official title Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
ClinicalTrials.gov ID: NCT05928936
What this study is testing
What is Sodium Bicarbonate?
Sodium Bicarbonate is an investigational medicine, given as an once-daily 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 goals of this project are to investigate the mechanisms and potential therapies related to exercise capacity in persons with chronic kidney disease (CKD).
- 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. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 75
You may be able to join if
- patients with CKD (Stages III and IV), kidney transplant recipients with varying degrees of kidney function, or persons without kidney disease as...
- sedentary and do not regularly exercise (defined as exercising \< 20 minutes twice per week)
- CKD patients must have stable renal function (no greater than a decline of estimated glomerular filtration (eGFR) of 1 cc/min/1.73 m2 per month over...
- comorbid hypertension
You likely can't join if
- severe CKD (eGFR\<15 cc/min)
- metabolic alkalosis
- current treatment with bicarbonate
- ongoing drug or alcohol abuse
- diabetic neuropathy, autonomic dysfunction
- any serious disease that might influence survival
See the full eligibility criteria
- patients with CKD (Stages III and IV), kidney transplant recipients with varying degrees of kidney function, or persons without kidney disease as matched study controls
- sedentary and do not regularly exercise (defined as exercising \< 20 minutes twice per week)
- CKD patients must have stable renal function (no greater than a decline of estimated glomerular filtration (eGFR) of 1 cc/min/1.73 m2 per month over the prior 6 months) and baseline serum bicarbonate 22-24 mmol/L
- comorbid hypertension
- severe CKD (eGFR\<15 cc/min)
- metabolic alkalosis
- current treatment with bicarbonate
- ongoing drug or alcohol abuse
- diabetic neuropathy, autonomic dysfunction
- any serious disease that might influence survival
- anemia with hemoglobin \<10 g/dL
- clinical evidence of heart failure
- volume overload or ejection fraction below 45%
- symptomatic heart disease by EKG, stress test, and/or history
- treatment with central α-agonists (clonidine)
- myocardial infarction or cerebrovascular accident within the past six months
- uncontrolled hypertension (BP\>170/100 mm Hg)
- low BP\<100/50 mm Hg
- surgery within the past 3 months
- pregnancy or plans to become pregnant
- inability to exercise on a stationary bicycle
- contraindication to temporary withdrawal of α- and β-blockers
- peripheral arterial disease
- class 3 obesity (BMI\>40)
- hypo- or hyperkalemia (K\ 5.0 meq/L)
- current use of immunosuppressive medications (including but not limited to steroids, cyclophosphamide, calcineurin inhibitors, mycophenolate, biologics, methotrexate, etc)
- arteriovenous (AV) fistula/graft
- any contraindication to MR scanning including cardiac pacemaker, cochlear implants, neurostimulators, implanted devices with metal, any metal in the body that could pose a hazard during scanning, history of...
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, 40 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.