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Amino Acid

L-Arginine for 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.
Must not have
treatment for diabetic neuropathy
heart failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am receiving treatment for nerve pain due to diabetes.
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I have heart failure.
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I am currently on immunosuppressant therapy.
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I am HIV positive.
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I am taking medication for menopause.
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I have had an organ transplant.
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I have had a heart attack.

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

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

Side effects data

From 2019 Phase 2 trial • 54 Patients • NCT01841281
17%
Hospitalization
8%
Gastroesophageal reflux disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
High Exhaled Nitric Oxide (NO) Phase 1, Treatment Arm
High Exhaled Nitric Oxide (NO) Washout Phase
High Exhaled Nitric Oxide (NO) Phase 2, Placebo Arm
High Exhaled Nitric Oxide (NO) Phase 1, 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

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~300

Find a Location

Who is running the clinical trial?

The University of Texas at ArlingtonLead Sponsor
44 Previous Clinical Trials
4,850 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
~0 spots leftby Dec 2024
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