Sickle Cell Disease Treatment With Arginine Therapy (STArT) Trial

PHASE3CompletedINTERVENTIONAL
Enrollment

271

Participants

Timeline

Start Date

June 21, 2021

Primary Completion Date

July 11, 2024

Study Completion Date

July 11, 2024

Conditions
Sickle Cell Disease
Interventions
DRUG

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).

OTHER

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).

Trial Locations (10)

19104

Children's Hospital of Philadelphia, Philadelphia

20010

Children's National Medical Center, Washington D.C.

30322

Children's Healthcare of Atlanta at Egleston, Atlanta

43205

Nationwide Children's Hospital, Columbus

53226

Medical College of Wisconsin/Wisconsin Children's Hospital, Wauwatosa

63110

Washington University/St. Louis Children's Hospital, St Louis

77030

Texas Children's Hospital/Baylor College of Medicine, Houston

90027

Children's Hospital Los Angeles, Los Angeles

94158

UCSF Benioff Children's Hospital, San Francisco

03322

Children's Healthcare of Atlanta at Hughes Spalding, Atlanta

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Claudia R. Morris

OTHER