Investigating exercise responses in patients with chronic kidney disease
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
This study is trying to see if exercise training and sodium bicarbonate can help people with chronic kidney disease improve their ability to exercise.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Drugs / interventions | methotrexate, cyclophosphamide |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Trial ID | NCT05928936 on ClinicalTrials.gov |
What this trial studies
This project aims to explore the mechanisms and potential therapies related to exercise capacity in individuals with chronic kidney disease (CKD). It focuses on understanding the neurovascular responses during exercise and how they contribute to exercise intolerance in CKD patients. The study will involve interventions such as sodium bicarbonate and exercise training, comparing responses in CKD patients to matched controls without kidney disease. By elucidating the underlying mechanisms of exercise dysfunction, the research seeks to identify new therapeutic strategies to improve physical capacity in these patients.
Who should consider this trial
Good fit: Ideal candidates include sedentary individuals with stages III and IV chronic kidney disease or kidney transplant recipients with stable renal function.
Not a fit: Patients with severe chronic kidney disease, metabolic alkalosis, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance exercise capacity and overall quality of life for patients with chronic kidney disease.
How similar studies have performed: While the specific mechanisms in CKD are less explored, similar studies in other chronic conditions have shown promising results in understanding exercise intolerance.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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\<3.5meq/L, 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 claustrophobia
Where this trial is running
Atlanta, Georgia and 1 other locations
- Emory Clinic — Atlanta, Georgia, United States (Recruiting)
- Atlanta VA Medical Center — Decatur, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Jeanie Park, MD — Emory University
- Study coordinator: Dana DaCosta
- Email: drdacos@emory.edu
- Phone: 404-727-7762
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.