Sickle Cell DiseasePhase 1/2R34 pK/PDNCT02447874
Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease
A Phase 1/2 study testing Arginine, Arginine (Loading) and Arginine (Continuous) in people with Sickle Cell Disease, run by Emory University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 21 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Arginine, Arginine (Loading) and Arginine (Continuous)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2015to Jan 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Children's Healthcare fo Atlanta at Hughes Spalding
Atlanta, Georgia, 30303
Arnetria Dancy, 404-778-1873, arnetria.dancy@emory.edu
- Recruiting
Children's Healthcare of Atlanta at Arthur M. Blank Hospital
Atlanta, Georgia, 30329
Arnetria Dancy, 404-778-1873, arnetria.dancy@emory.edu
About this study
Official title: Arginine Therapy for the Treatment of Vaso-Occlusive Events in Children With Severe Sickle Cell Disease
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.
Read the detailed description
Arginine is a simple amino acid that is found in many foods and is part of the proteins in a human's body. Patients with sickle cell disease have low levels of the amino acid arginine and these low levels may be related to pain episodes. Increasing levels of arginine in the blood may lower pain and/or lower the amount of pain medication (like morphine) that is needed to treated them. It may also decrease the amount of time spent in the hospital.
Available data suggest that, L-arginine is a safe \& efficacious intervention with narcotic-sparing effects in pediatric SCD patients with VOE. The addition of a higher loading dose to the standard dose or use of a continuous infusion may provide additional clinical benefits by overcoming multiple mechanisms that limit global arginine bioavailability in SCD.
- Conditions
- Sickle Cell Disease
- Being tested
- Arginine, Arginine (Loading), Arginine (Continuous)
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArginineDrug
Also called Arginine Hydrochloride Injection, R-Gene® 10
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)Drug
Also called Arginine Hydrochloride Injection, R-Gene® 10
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)Drug
Also called Arginine Hydrochloride Injection, R-Gene® 10
Arginine will be dispensed intravenously (in the vein) as a continuous IV infusion of 300 mg/kg/24hr
| Study group | Role | What they receive |
|---|---|---|
| Standard dose | Experimental | 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 Receives: Drug: Arginine |
| Loading dose + standard dose | Experimental | 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 Receives: Drug: Arginine; Drug: Arginine (Loading) |
| Loading dose + continuous infusion | Experimental | 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 Receives: Drug: Arginine (Loading); Drug: Arginine (Continuous) |
| Non-Randomized Loading dose 500 mg/kg + standard dose | Experimental | 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. Receives: Drug: Arginine (Loading) |
| Non-Randomized Loading dose 300 mg/kg + standard dose | Experimental | 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. Receives: Drug: Arginine (Loading) |
| Non-Randomized Loading dose 400mg/kg + standard dose | Experimental | 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. Receives: Drug: Arginine (Loading) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of IV arginine, measured by plasma arginine concentration over time
Total time plasma arginine levels are maintained above the half-saturating concentration (Km) of cationic amino acid transporter protein-1 (CAT-1), which is 150 µM (normal range of extracellular plasma arginine concentration). pK samples will be collected at 6 time-points within 8 hours: prior to arginine treatment (time 0), and at 60, 90, 120 minutes, 4 and 8 hours after the initiation of arginine therapy, and then every 24 hours up to 7 days.
Measured: Day 1 through study completion, an average of up to 7 days
Change in nitric oxide metabolites
The formation of NO metabolites will be measured by determination of its stable end products in serum; nitrite (NO2-) and nitrate (NO3-). Change in nitric oxide metabolites will be calculated as the difference in metabolites from the time prior to arginine treatment (baseline) to the end of the intervention period.
Measured: Baseline, day 1 through study completion, an average of up to 7 days
Secondary outcomes (12)
Area Under the Plasma Concentration -Time Curve (AUC) From Time 0 to the Time of the Last Quantifiable Concentration for Arginine
AUC is derived from drug concentration and time so it gives a measure of how much and how long a drug stays in a body. AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc])
Measured: Day 1
Maximum observed plasma concentration of arginine
Maximum measured concentration of the arginine in plasma
Measured: Day 1
Apparent clearance of arginine
The clearance of a drug measures the rate at which the drug is removed from the body after the dose. Clearance of arginine after intravenous administration on day 1.
Measured: Day 1
Terminal elimination half-life (t1/2) for arginine
Terminal phase elimination half-life (t1/2) is the time required for half of the drug to be eliminated from the plasma.
Measured: Day 1
Change in red blood cell (RBC) arginine
Change in rbc arginine will be calculated as rbc arginine at the end of arginine administration minus rbc arginine at baseline.
Measured: Baseline, day 1 through study completion, an average of up to 7 days
Daily urine arginine
Total amount of arginine excreted in urine daily
Measured: From Day 1 until study completion, an average of up to 7 days
Global arginine bioavailability (GABR)
GABR represents a measure of endothelial function. GABR will be calculated by arginine divided by the sum of ornithine plus citrulline [arginine/(ornithine+citrulline)].
Measured: From enrollment through study completion, an average of up to 7 days
Change in asymmetric dimethylarginine (ADMA) levels
ADMA is is a metabolic by-product of continual protein modification processes and interferes with L-arginine in the production of nitric oxide. Change in ADMA levels will be calculated as ADMA levels at the end of arginine administration minus ADMA levels at baseline.
Measured: Baseline, day 1 and through study completion, an average of up to 7 days
Modeling nitric oxide (NOx) level versus plasma arginine level
Modeling nitric oxide (NOx) level versus plasma arginine level will be measured.
Measured: From enrollment through study completion, an average of up to 7 days
Biomarkers of hemolysis
Biomarkers of hemolysis (lactate dehydrogenase, hemoglobin, reticulocytes, arginase, indirect bilirubin) represent intravascular hemolysis and nitric oxide bioavailability.
Measured: From enrollment through study completion, an average of up to 7 days
Erythrocyte glutathione levels
Erythrocyte glutathione is a biomarker for oxidative stress. It will be measured by using liquid chromatography.
Measured: From enrollment through study completion, an average of up to 7 days
Level of cytokines
Cytokines are biomarkers for inflammation. Cell supernatants will be collected and analyzed for different cytokines.
Measured: From enrollment through study completion, an average of up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Healthcare of Atlanta, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Claudia R. Morris, Emory University
- Investigators
- Claudia Morris, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447874
- Sponsor's protocol ID
- IRB00077736
- Other IDs
- 1K24AT009893-01
- Acronym
- R34 pK/PD
- Status last verified
- Jul 2026
- First submitted
- 15 May 2015
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Morris CR, Brown LAS, Reynolds M, Dampier CD, Lane PA, Watt A, Kumari P, Harris F, Manoranjithan S, Mendis RD, Figueroa J, Shiva S. Impact of arginine therapy on mitochondrial function in children with sickle cell disease during vaso-occlusive pain. Blood. 2020 Sep 17;136(12):1402-1406. doi: 10.1182/blood.2019003672.
PubMed 32384147Korman R, Hatabah D, Brown LA, Harris F, Wilkinson H, Rees CA, Bakshi N, Archer DR, Dampier C, Morris CR. Impact of arginine therapy on kyotorphin in children with sickle cell disease and vaso-occlusive pain. Blood Adv. 2024 Jun 25;8(12):3267-3271. doi: 10.1182/bloodadvances.2023012209.
PubMed 38527291Korman R, Yasmine M, Hatabah D, Alzraikat N, Harris F, Brown LA, Chonat S, Bakshi N, Rees CA, Dampier C, Morris CR. Secretory Phospholipase A2 in Patients With Sickle Cell Disease Hospitalized for Vaso-Occlusive Pain Episodes. Pediatr Blood Cancer. 2026 Aug 4:e70615. doi: 10.1002/1545-5017.70615. Online ahead of print.
PubMed 42549972
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arginine Therapy for the Treatment of Vaso-Occlusive Events in Children With Severe Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT02447874
- Acronym / sponsor ID
- R34 pK/PD / IRB00077736
- Conditions
- Sickle Cell Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Children's Healthcare of Atlanta, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- May 2015
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 19 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Arginine is a simple amino acid that is found in many foods and is part of the proteins in a human's body. Patients with sickle cell disease have low levels of the amino acid arginine and these low levels may be related to pain episodes. Increasing levels of arginine in the blood may lower pain and/or lower the amount of pain medication (like morphine) that is needed to treated them. It may also decrease the amount of time spent in the hospital.
Available data suggest that, L-arginine is a safe \& efficacious intervention with narcotic-sparing effects in pediatric SCD patients with VOE. The addition of a higher loading dose to the standard dose or use of a continuous infusion may provide additional clinical benefits by overcoming multiple mechanisms that limit global arginine bioavailability in SCD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Standard dose | Experimental | Drug: ArginineSubjects 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 |
| Loading dose + standard dose | Experimental | Drug: Arginine, Drug: Arginine (Loading)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 |
| Loading dose + continuous infusion | Experimental | Drug: Arginine (Loading), Drug: Arginine (Continuous)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 |
| Non-Randomized Loading dose 500 mg/kg + standard dose | Experimental | Drug: Arginine (Loading)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. |
| Non-Randomized Loading dose 300 mg/kg + standard dose | Experimental | Drug: Arginine (Loading)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. |
| Non-Randomized Loading dose 400mg/kg + standard dose | Experimental | Drug: Arginine (Loading)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. |
Who may qualify
- Ages
- 7 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArginineAlso: Arginine Hydrochloride Injection, R-Gene® 10Arginine 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 | Drug | Loading dose + standard dose, Standard dose |
| Arginine (Loading)Also: Arginine Hydrochloride Injection, R-Gene® 10Arginine 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. | Drug | Loading dose + continuous infusion, Loading dose + standard dose, Non-Randomized Loading dose 300 mg/kg + standard dose, Non-Randomized Loading dose 400mg/kg + standard dose, Non-Randomized Loading dose 500 mg/kg + standard dose |
| Arginine (Continuous)Also: Arginine Hydrochloride Injection, R-Gene® 10Arginine will be dispensed intravenously (in the vein) as a continuous IV infusion of 300 mg/kg/24hr | Drug | Loading dose + continuous infusion |
Primary outcome
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
Total time plasma arginine levels are maintained above the half-saturating concentration (Km) of cationic amino acid transporter protein-1 (CAT-1), which is 150 µM (normal range of extracellular plasma arginine concentration). pK samples will be collected at 6 time-points within 8 hours: prior to arginine treatment (time 0), and at 60, 90, 120 minutes, 4 and 8 hours after the initiation of arginine therapy, and then every 24 hours up to 7 days.
Change in nitric oxide metabolites
Time frame: Baseline, day 1 through study completion, an average of up to 7 days
The formation of NO metabolites will be measured by determination of its stable end products in serum; nitrite (NO2-) and nitrate (NO3-). Change in nitric oxide metabolites will be calculated as the difference in metabolites from the time prior to arginine treatment (baseline) to the end of the intervention period.
12 secondary outcomes
Area Under the Plasma Concentration -Time Curve (AUC) From Time 0 to the Time of the Last Quantifiable Concentration for Arginine
Time frame: Day 1
Maximum observed plasma concentration of arginine
Time frame: Day 1
Apparent clearance of arginine
Time frame: Day 1
Terminal elimination half-life (t1/2) for arginine
Time frame: Day 1
Change in red blood cell (RBC) arginine
Time frame: Baseline, day 1 through study completion, an average of up to 7 days
Daily urine arginine
Time frame: From Day 1 until study completion, an average of up to 7 days
Global arginine bioavailability (GABR)
Time frame: From enrollment through study completion, an average of up to 7 days
Change in asymmetric dimethylarginine (ADMA) levels
Time frame: Baseline, day 1 and through study completion, an average of up to 7 days
Modeling nitric oxide (NOx) level versus plasma arginine level
Time frame: From enrollment through study completion, an average of up to 7 days
Biomarkers of hemolysis
Time frame: From enrollment through study completion, an average of up to 7 days
Erythrocyte glutathione levels
Time frame: From enrollment through study completion, an average of up to 7 days
Level of cytokines
Time frame: From enrollment through study completion, an average of up to 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Results publication: PubMed 32384147Morris CR, Brown LAS, Reynolds M, Dampier CD, Lane PA, Watt A, Kumari P, Harris F, Manoranjithan S, Mendis RD, Figueroa J, Shiva S. Impact of arginine therapy on mitochondrial function in children with sickle cell disease during vaso-occlusive pain. Blood. 2020 Sep 17;136(12):1402-1406. doi: 10.1182/blood.2019003672.
- Results publication: PubMed 38527291Korman R, Hatabah D, Brown LA, Harris F, Wilkinson H, Rees CA, Bakshi N, Archer DR, Dampier C, Morris CR. Impact of arginine therapy on kyotorphin in children with sickle cell disease and vaso-occlusive pain. Blood Adv. 2024 Jun 25;8(12):3267-3271. doi: 10.1182/bloodadvances.2023012209.
- Derived from this study: PubMed 42549972Korman R, Yasmine M, Hatabah D, Alzraikat N, Harris F, Brown LA, Chonat S, Bakshi N, Rees CA, Dampier C, Morris CR. Secretory Phospholipase A2 in Patients With Sickle Cell Disease Hospitalized for Vaso-Occlusive Pain Episodes. Pediatr Blood Cancer. 2026 Aug 4:e70615. doi: 10.1002/1545-5017.70615. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claudia Morris, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Arginine, Arginine (Loading) and Arginine (Continuous) in people with Sickle Cell Disease, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reshika Mendis, MBBS (404-785-4525, Reshika.mendis@choa.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02447874, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.