L-arginine to Reduce Sympathetic Nerve Activity in CKD Patients (NCT03982160) | Clinical Trial Compass
Active — Not RecruitingPhase 4
L-arginine to Reduce Sympathetic Nerve Activity in CKD Patients
United States15 participantsStarted 2018-02-01
Plain-language summary
Chronic kidney disease (CKD) is associated with a higher risk of cardiovascular disease and death. An overactive sympathetic nervous system in CKD patients is one of the major mechanisms increasing the cardiovascular risks in this patient population. A potential signal driving sympathetic nerve activity (SNA) involves accumulation of the endogenous nitric oxide synthase (NOS) inhibitor asymmetric dimethylarginine (ADMA). ADMA is elevated in CKD and is a strong, independent predictor of future cardiovascular events in these patients. .
The goal of this study is to determine whether overcoming the accumulation of endogenous ADMA with acute L-arginine infusion reduces SNA in CKD patients.
Who can participate
Age range
35 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing whether an infusion of L-arginine can reduce overactive nerve signals — called muscle sympathetic nerve activity — in people with chronic kidney disease. Given where I am in my CKD, is my level of nerve system overactivity something that's actually a concern for my care right now?
2Since this is a Phase 4 trial, the drug itself has already been approved for other uses — but does that mean the risks of L-arginine infusion are well understood for someone with my stage of CKD, and are there any kidney-specific risks I should know about?
3The trial is active but no longer recruiting new patients, so I may not be able to join — but could you walk me through what the researchers are trying to learn about sympathetic nervous system activity and CKD, and whether that finding might eventually change how my condition is managed?
4Are there currently any standard-of-care treatments that already address sympathetic nerve overactivity in CKD, and would pursuing one of those be a more immediate option for me while this trial completes?
5Even if I can't enroll, are there other ongoing studies or approaches targeting sympathetic nervous system activity in CKD that my care team is aware of and that might be worth exploring?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Muscle sympathetic nerve activity (MSNA) will be reduced after L-arginine infusion