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Sickle Cell Disease Treatment With Arginine Therapy (STArT) Trial
Sponsor: Claudia R. Morris
Summary
The trial is designed to test intravenous (IV) arginine therapy in children with sickle cell disease (SCD) and vaso-occlusive painful episodes (VOE) to further knowledge on efficacy and safety of this orphan drug.
Key Details
Gender
All
Age Range
3 Years - 21 Years
Study Type
INTERVENTIONAL
Enrollment
271
Start Date
2021-06-21
Completion Date
2024-07-11
Last Updated
2026-06-23
Healthy Volunteers
No
Conditions
Interventions
L-Arginine Hydrochloride
A one-time L-arginine hydrochloride loading dose of 200 mg/kg will be administered intravenously (IV) followed by a standard dose of 100 mg/kg given by IV three times per day (TID).
Normal saline
A placebo of normal saline will be administered by IV with a loading dose of 2ml/kg followed by 1ml/kg given by IV three times per day (TID).
Locations (10)
Children's Hospital Los Angeles
Los Angeles, California, United States
UCSF Benioff Children's Hospital
San Francisco, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Children's Healthcare of Atlanta at Hughes Spalding
Atlanta, Georgia, United States
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States
Washington University/St. Louis Children's Hospital
St Louis, Missouri, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Texas Children's Hospital/Baylor College of Medicine
Houston, Texas, United States
Medical College of Wisconsin/Wisconsin Children's Hospital
Wauwatosa, Wisconsin, United States