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Amino Acid

L-Arginine for Chronic Kidney Disease

Phase 4
Recruiting
Led By Paul J Fadel, PhD
Research Sponsored by The University of Texas at Arlington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men and women 35 to 75 years of age
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights

Study Summary

This trialaims to find out if reducing the accumulation of a substance in CKD patients that increases the risk of cardiovascular events can reduce their risk.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
L-arginine may cause minor side effects like gastrointestinal discomfort and bloating. In some cases it could lead to allergies or changes in blood sugar levels. The exact side effects will be monitored closely during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 35 and 75 years old.
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My kidney function is moderately to severely reduced.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Muscle sympathetic nerve activity (MSNA) will be reduced after L-arginine infusion

Side effects data

From 2019 Phase 2 trial • 54 Patients • NCT01841281
5%
Hospitalization
100%
80%
60%
40%
20%
0%
Study treatment Arm
High Exhaled Nitric Oxide (NO) Washout Phase
High Exhaled Nitric Oxide (NO) Phase 1, Placebo Arm
High Exhaled Nitric Oxide (NO) Phase 1, Treatment Arm
High Exhaled Nitric Oxide (NO) Phase 2, Placebo Arm
High Exhaled Nitric Oxide (NO) Phase 2, Treatment Arm
Low Exhaled Nitric Oxide (NO) Phase 1, Treatment Arm
Low Exhaled Nitric Oxide (NO) Phase 1, Placebo Arm
Low Exhaled Nitric Oxide (NO) Washout Phase
Low Exhaled Nitric Oxide (NO) Phase 2, Treatment Arm
Low Exhaled Nitric Oxide (NO) Phase 2, Placebo Arm

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
L-Arginine
2018
Completed Phase 3
~290

Find a Location

Who is running the clinical trial?

The University of Texas at ArlingtonLead Sponsor
43 Previous Clinical Trials
4,923 Total Patients Enrolled
Paul J Fadel, PhDPrincipal InvestigatorUniversity of Texas at Arlington
3 Previous Clinical Trials
44 Total Patients Enrolled

Media Library

L-Arginine (Amino Acid) Clinical Trial Eligibility Overview. Trial Name: NCT03982160 — Phase 4
Chronic Kidney Disease Research Study Groups: L-arginine, Saline
Chronic Kidney Disease Clinical Trial 2023: L-Arginine Highlights & Side Effects. Trial Name: NCT03982160 — Phase 4
L-Arginine (Amino Acid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03982160 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
L-arginine to Reduce Sympathetic Nerve Activity in CKD Patients
Paul Fadel 2018. "L-arginine to Reduce Sympathetic Nerve Activity in CKD Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03982160.
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~1 spots leftby Dec 2024
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