15 Participants Needed

L-Arginine for Kidney Disease

Recruiting at 1 trial location
PJ
Overseen ByPaul J Fadel, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: The University of Texas at Arlington
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking menopausal drugs or treatment for diabetic neuropathy, you may not be eligible to participate.

What evidence supports the effectiveness of the drug L-Arginine for kidney disease?

Some studies suggest that L-Arginine might help improve kidney function in certain conditions by increasing blood flow and reducing inflammation, but its effects can vary depending on the specific type of kidney disease. In animal studies, L-Arginine has shown benefits in conditions like hypertension and diabetes-related kidney issues, but its effectiveness in humans is not fully understood and may not be beneficial in all cases.12345

Is L-Arginine safe for humans with kidney disease?

L-Arginine has shown both beneficial and harmful effects in animal studies, depending on the specific kidney condition. In humans, it does not change the course of chronic glomerular diseases, but it may be beneficial in some other kidney conditions. More research is needed to fully understand its safety and effects.14678

How does the drug L-Arginine differ from other treatments for kidney disease?

L-Arginine is unique because it is a semi-essential amino acid that helps produce nitric oxide, which can improve blood flow and kidney function. Unlike other treatments, it may have both beneficial and harmful effects depending on the specific kidney condition, and its role in treating kidney disease is not fully understood.34589

What is the purpose of this trial?

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.

Research Team

PJ

Paul J Fadel, PhD

Principal Investigator

University of Texas at Arlington

Eligibility Criteria

This trial is for adults aged 35-75 with moderate to severe chronic kidney disease (stages 3 and 4), who have a specific level of kidney function. It's not open to those with heart failure, severe anemia, HIV, pregnant or breastfeeding women, very low blood pressure or high resting heart rate, current smokers, cancer patients undergoing treatment, or those on certain medications.

Inclusion Criteria

I am between 35 and 75 years old.
My kidney function is moderately to severely reduced.

Exclusion Criteria

anemia (hemoglobin <8 g/dl)
I am receiving treatment for nerve pain due to diabetes.
I have heart failure.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive intravenous infusion of L-arginine or saline for 30 minutes

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

  • L-Arginine
  • Placebo
Trial Overview The study tests if L-arginine infusion can reduce overactivity in the nervous system among CKD patients by counteracting ADMA accumulation. Participants will either receive this amino acid or a placebo in order to compare outcomes.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: L-arginineExperimental Treatment1 Intervention
Intravenous infusion of L-arginine (250-350 mg/kg) will be performed for 30 minutes.
Group II: SalinePlacebo Group1 Intervention
Saline will be infused for 30 minutes

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas at Arlington

Lead Sponsor

Trials
48
Recruited
7,300+

Findings from Research

Modifying dietary L-arginine intake can have both positive and negative effects on kidney health, highlighting the complexity of its metabolism in renal diseases.
While restricting L-arginine can help reduce renal fibrosis in low protein diets, increasing L-arginine may be harmful in certain kidney disorders, particularly those with high iNOS expression.
From rats to man: a perspective on dietary L-arginine supplementation in human renal disease.Peters, H., Border, WA., Noble, NA.[2019]
In a study of proteinuric patients with moderate chronic renal failure (CRF), L-arginine supplementation did not improve renal function or reduce proteinuria after six months of treatment, indicating a lack of efficacy in this population.
Despite an increase in plasma arginine levels with supplementation, there was no significant enhancement in nitric oxide (NO) activity or improvement in renal functional reserve, suggesting that the NO system may not be impaired in these patients.
Randomized, double-blind, placebo-controlled study of arginine supplementation in chronic renal failure.De Nicola, L., Bellizzi, V., Minutolo, R., et al.[2013]
L-arginine supplementation in young renal allograft recipients treated with cyclosporin A did not significantly improve renal function or reduce proteinuria, indicating limited efficacy in this patient group.
However, L-arginine did increase urinary excretion of urea and nitrates, suggesting some metabolic effects, but the unchanged levels of cGMP indicate that the expected nitric oxide pathway may be inhibited in these patients.
L-arginine supplementation in young renal allograft recipients with chronic transplant dysfunction.Zhang, XZ., Ardissino, G., Ghio, L., et al.[2013]

References

From rats to man: a perspective on dietary L-arginine supplementation in human renal disease. [2019]
Randomized, double-blind, placebo-controlled study of arginine supplementation in chronic renal failure. [2013]
L-arginine supplementation in young renal allograft recipients with chronic transplant dysfunction. [2013]
Role of L-arginine in the pathogenesis and treatment of renal disease. [2023]
Can L-arginine manipulation reduce renal disease? [2013]
Enhancement of nitric oxide synthesis by L-arginine supplementation in renal disease: is it good or bad? [2013]
L-arginine: a new opportunity in the management of clinical derangements in dialysis patients. [2016]
Role of arginine in health and in renal disease. [2017]
Dietary supplementation with L-arginine ameliorates the progression of renal disease in rats with subtotal nephrectomy. [2019]
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