Using L-arginine to lower nerve activity in chronic kidney disease patients
Role of Decreased Nitric Oxide in the Tonic Elevation of Resting Sympathetic Nerve Activity in Chronic Kidney Disease Patients
This study is testing if giving L-arginine can help lower nerve activity and blood pressure in people with chronic kidney disease.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 35 Years to 75 Years |
| Sex | All |
| Sponsor | The University of Texas at Arlington Academic / other |
| Locations | 2 sites (Newark, Delaware and 1 other locations) |
| Trial ID | NCT03982160 on ClinicalTrials.gov |
What this trial studies
This study investigates whether L-arginine infusion can reduce sympathetic nerve activity and blood pressure in patients with chronic kidney disease (CKD). It focuses on the role of asymmetric dimethylarginine (ADMA), which is elevated in CKD and contributes to cardiovascular risks. Participants will undergo a series of tests after fasting and will be monitored for changes in nerve activity and blood pressure following L-arginine or placebo administration. The study aims to provide insights into potential therapeutic strategies for managing cardiovascular risks in CKD patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 35 to 75 with Stage 3 or 4 chronic kidney disease and specific glomerular filtration rates.
Not a fit: Patients with recent myocardial infarction, heart failure, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower cardiovascular risks for patients with chronic kidney disease.
How similar studies have performed: While the specific use of L-arginine in this context is novel, previous studies have explored similar interventions with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * CKD patients classified as Stage 3 and 4 of National Kidney Foundation Classification with estimated glomerular filtration rate (GFR) between 15 and 59 mL/min/1.73 m2 according to the Modification of Diet in Renal Disease (MDRD) formula based on serum creatinine, age, gender, and race. * Men and women 35 to 75 years of age Exclusion Criteria: * myocardial infarction * heart failure * anemia (hemoglobin \<8 g/dl) * cancer with current treatment * previous organ transplantation * immunosuppressant therapy * human immunodeficiency virus infection * pregnancy and/or lactating * current tobacco use * taking menopausal drugs (estradiol) * treatment for diabetic neuropathy * resting heart rate ≥ 100 bpm and * systolic blood pressure ≤ 90 mmHg
Where this trial is running
Newark, Delaware and 1 other locations
- University of Delaware — Newark, Delaware, United States (Recruiting)
- UT Southwestern — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Paul J Fadel, PhD — University of Texas at Arlington
- Study coordinator: Paul J Fadel, PhD
- Email: Paul.Fadel@uta.edu
- Phone: 8172724653
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.