← Back to Search

Amino Acid

Arginine Therapy for Sickle Cell Disease (STArT Trial)

Phase 3
Recruiting
Led By Claudia Morris, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Established diagnosis of sickle cell disease (any genotype); AND
Pain requiring medical care in an acute care setting (ED, hospital ward, day hospital, clinic) not attributable to non-sickle cell causes, treated with parenteral opioids.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights

STArT Trial Summary

This trial is testing whether IV arginine therapy is effective and safe for children with VOE in SCD.

Who is the study for?
The STArT trial is for children and young adults aged 3-21 with sickle cell disease experiencing pain episodes needing medical care. They must not have had certain treatments or hospitalizations recently, be stable without severe anemia, and able to understand English or Spanish.Check my eligibility
What is being tested?
This study tests IV arginine therapy versus saline (a placebo) in managing pain during vaso-occlusive episodes in sickle cell patients. It aims to determine the effectiveness and safety of arginine compared to a standard treatment.See study design
What are the potential side effects?
While specific side effects are not listed here, arginine therapy could potentially cause allergic reactions, low blood pressure, electrolyte imbalances, or exacerbate existing conditions related to sickle cell disease.

STArT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with sickle cell disease.
Select...
I have had severe pain from sickle cell disease treated with strong painkillers.
Select...
I am between 3 and 21 years old.

STArT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in time-to-crisis resolution
Secondary outcome measures
Change in PROMIS Fatigue score
Pain
Change in PROMIS Pain Interference score
+2 more
Other outcome measures
Change in Arginine bioavailability
Change in Medication Quantification Score (MQS)
Change in Pediatric PROMIS score
+3 more

STArT Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arginine HydrochlorideExperimental Treatment1 Intervention
Arginine is a nutritional supplement in parenteral form
Group II: PlaceboPlacebo Group1 Intervention
Normal saline

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,818 Previous Clinical Trials
47,294,937 Total Patients Enrolled
Emory UniversityLead Sponsor
1,632 Previous Clinical Trials
2,556,117 Total Patients Enrolled
Claudia R. MorrisLead Sponsor

Media Library

Arginine Hydrochloride (Amino Acid) Clinical Trial Eligibility Overview. Trial Name: NCT04839354 — Phase 3
Sickle Cell Disease Research Study Groups: Arginine Hydrochloride, Placebo
Sickle Cell Disease Clinical Trial 2023: Arginine Hydrochloride Highlights & Side Effects. Trial Name: NCT04839354 — Phase 3
Arginine Hydrochloride (Amino Acid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04839354 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study widely available to patients in America?

"This trial is currently taking place at 10 locations, which include Nationwide Children's Hospital in Columbus, Medical College of Wisconsin/Wisconsin Children's Hospital in Wauwatosa, and Children's Hospital Los Angeles in Los Angeles."

Answered by AI

What medical conditions is Arginine Hydrochloride commonly used to treat?

"Arginine Hydrochloride is a medical treatment that is often used to manage pituitary dwarfism. This drug can also be used to ameliorate conditions like pituitary stimulant, amino acid supplementation, and enzymes."

Answered by AI

What does the FDA think about Arginine Hydrochloride?

"Arginine Hydrochloride is estimated to be a safe drug, with a score of 3. This is because it is a Phase 3 trial, meaning that there is both some evidence of efficacy as well as multiple rounds of supportive safety data."

Answered by AI

Are there any available positions for patients who wish to participate in this research?

"The listed clinical trial on clinicaltrials.gov is currently looking for willing participants. The study was first posted on June 21st, 2021 and was last updated on January 12th, 2022."

Answered by AI

Are individuals above the age of 45 able to participate in this research project?

"According to the eligibility requirements listed on the website, patients must be aged 3 to 21 in order to participate in this trial. Out of the 230 total trials, 137 are for patients that are under 18 and 93 are for patients over the age of 65."

Answered by AI

For whom is this trial designed?

"Anemic and sickle cell patients between the ages of 3 and 21 are encouraged to sign up for this clinical trial. A little over 300 patients are needed for the study."

Answered by AI

Are there other ongoing tests that are using Arginine Hydrochloride?

"Arginine Hydrochloride was first researched in 2007 at Surgical Intensive Care Unit Regional Hospital Jessa. Since that time, there have been 297 completed studies. Currently, 14 clinical trials are still recruiting patients, with a large number of these studies based in Columbus, Ohio."

Answered by AI

Have similar investigations been conducted in the past?

"Arginine Hydrochloride has been under scientific investigation since 2007. The initial study was completed in that year and funded by Baxter Healthcare Corporation. This trial, which had 4640 participants, led to Arginine Hydrochloride's Phase 4 drug approval. As of now, there are 14 clinical trials underway for Arginine Hydrochloride in 24 cities and 11 countries."

Answered by AI
~188 spots leftby Apr 2027