Recruiting
Phase 1
Phase 2

Arginine Therapy

Sponsor:

Emory University

Code:

NCT02447874

Conditions

Sickle Cell Disease

Eligibility Criteria

Sex: All

Age: 7 - 21

Healthy Volunteers: Not accepted

Interventions

Arginine

Arginine (Loading)

Arginine (Continuous)

Study Details

Brief summary:

The purpose of this study is to determine whether giving extra arginine to patients with sickle cell disease seeking treatment for vaso-occlusive painful events (VOE) will decrease pain scores, decrease need for pain medications or decrease length of hospital stay or emergency department visit.

Conditions

Sickle Cell Disease

Study ID

NCT02447874

Start date

May, 2015

Status verified date

Jul, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Established diagnosis of sickle cell disease--Hemoglobin SS (Hb-SS) or Sβᴼ-thalassemia
  • 7-21 years of age
  • Weight >= 25kg (55lbs)
  • Pain requiring medical care in an acute care setting (emergency department (ED), hospital ward, day hospital, clinic) requiring parenteral opioids, not attributable to non-sickle cell causes.

Exclusion Criteria:

  • Decision to discharge home from acute care setting.
  • Diagnosis of sickle cell disease with any of the following types: hemoglobin SC disease (HbSC), hemoglobin beta thalassemia (Hb-Beta Thal), hemoglobin SD disease (HbSD), hemoglobin SE disease (HbSE), hemoglobin SO disease (HbSO), hemoglobin AS carrier (Hb AS)
  • Hemoglobin less than 5 gm/dL
  • Immediate Red cell transfusion anticipated
  • Renal dysfunction: Creatinine >1.0 or 2 x baseline
  • Mental status or neurological changes
  • Acute stroke or clinical concern for stroke
  • Pregnancy
  • Allergy to arginine
  • Previous hospitalization < 7 days
  • Use of inhaled nitric oxide, sildenafil or arginine within the last 14 days
  • Not an appropriate candidate in the investigator's judgement

Study Design

Enrollment

21 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Standard dose

Subjects with sickle cell disease (SCD) and vaso-occlusive painful events (VOE) will be randomized to receive an intravenous (IV) infusion of a standard dose of arginine (100 mg/kg) three times a day for seven days or until discharged from the hospital, whichever occurs first

experimental: Loading dose + standard dose

Subjects with sickle cell disease and vaso-occlusive painful events (VOE) will be randomized to receive an intravenous (IV) infusion of an initial loading dose of arginine (200 mg/kg) given over 30 minutes and then receive an intravenous (IV) infusion of a standard dose of arginine (100 mg/kg) three times a day for seven days or until discharged from the hospital, whichever occurs first

experimental: Loading dose + continuous infusion

Subjects with sickle cell disease and vaso-occlusive painful events (VOE) will be randomized to receive an intravenous (IV) infusion of an initial loading dose of arginine (200 mg/kg) given over 30 minutes and then receive a continuous intravenous (IV) infusion of 300 mg/kg/24hr for 7 days or until discharged from the hospital, whichever occurs first

experimental: Non-Randomized Loading dose 500 mg/kg + standard dose

Arginine will be dispensed intravenously (in the vein) as an initial bolus (loading) arginine dose at 500 mg/kg once, followed by a standard dose of 100mg/kg every 8 hours until discharge or for a total of 21 doses of arginine, whichever comes first.

experimental: Non-Randomized Loading dose 300 mg/kg + standard dose

Arginine will be dispensed intravenously (in the vein) as an initial bolus (loading) arginine dose at 300 mg/kg once, followed by a standard dose of 100mg/kg every 8 hours until discharge or for a total of 21 doses of arginine, whichever comes first.

experimental: Non-Randomized Loading dose 400mg/kg + standard dose

Arginine will be dispensed intravenously (in the vein) as an initial bolus (loading) arginine dose at 400 mg/kg once, followed by a standard dose of 100mg/kg every 8 hours until discharge or for a total of 21 doses of arginine, whichever comes first.

Interventions

Arginine

Arginine will be dispensed intravenously (in the vein) in the standard dose of arginine as 100 mg/kg three times a day for seven days or until discharge.

  • Loading dose: 200 mg/kg once
  • Continuous IV: 300 mg/kg/24 hours

Arginine (Loading)

Arginine will be dispensed intravenously (in the vein) as an initial bolus (loading) at each specified group dose once, followed by a standard dose of 100mg/kg every 8 hours until discharge or for a total of 21 doses of arginine, whichever comes first.

Arginine (Continuous)

Arginine will be dispensed intravenously (in the vein) as a continuous IV infusion of 300 mg/kg/24hr

Primary outcome measure

  • Pharmacokinetics of IV arginine, measured by plasma arginine concentration over time [ Time Frame: Day 1 through study completion, an average of up to 7 days ]
  • Change in nitric oxide metabolites [ Time Frame: Baseline, day 1 through study completion, an average of up to 7 days ]

Central Contacts and Locations

Central contacts

Reshika Mendis, MBBS

404-785-4525Reshika.mendis@choa.org

Claudia Morris, MD

404 727-5500claudia.r.morris@emory.edu

Locations

Children's Healthcare fo Atlanta at Hughes Spalding

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Arnetria Dancy

404-778-1873arnetria.dancy@emory.edu

Children's Healthcare of Atlanta at Arthur M. Blank Hospital

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Arnetria Dancy

404-778-1873arnetria.dancy@emory.edu

More Information

Sponsor

Emory University

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-07-29.