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Patient-Oriented Research in Arginine Deficiency Syndromes

Award Number: K24AT009893
ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP
PERIOD OF PERFORMANCE START DATE: 09/24/2018
PERIOD OF PERFORMANCE END DATE: 07/31/2028

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Patient-Oriented Research in Arginine Deficiency Syndromes - This K24 renewal application entitled “Patient-Oriented Research (POR) in Arginine (ARG) Deficiency Syndromes” seeks 5 years of additional support for protected time to maintain the principal investigator’s (PI) mentoring activities, promote her career development & provide ongoing momentum to advance the applicant’s research evaluating ARG therapy in sickle cell disease (SCD) and beyond. ARG is a nutritional supplement & obligate substrate for production of nitric oxide, a potent vasodilator that depletes during SCD-related pain episodes. The PI & her mentees have completed several randomized, double-blinded, placebo-controlled trials (RCT) of ARG therapy in children with SCD & pain requiring hospitalization in both the US & Nigeria. These studies combined found that ARG replacement therapy (ART) has opioid-sparing effects, improved pain scores & cardiopulmonary function, decreased pain medication use & time-to-crisis-resolution and was associated with a shorter hospital stay compared to placebo. The PI and colleagues also observed a dose-dependent impact of ART that improved mitochondrial function & decreased oxidative stress in children with SCD-pain. With recent NHLBI funding for a multicenter Phase 3 RCT utilizing the Pediatric Emergency Care Applied Research Network (PECARN), the PI plans to perform the definitive study - Sickle Cell Disease Treatment with Arginine Therapy (STArT) to determine the efficacy & safety of ART. Pain in SCD is the leading cause of emergency room (ED) visits & hospitalizations, associated with an increased mortality rate. There are no current therapies to treat the underlying mechanisms of acute pain, with interventions limited to hydration & analgesia. The PI hypothesizes that ARG is a safe & inexpensive nutritional supplement with opioid-sparing effects in children with SCD & pain. The STArT trial will provide essential data for product development & will ultimately help gain FDA product approval for SCD if benefits of ART are confirmed. The results of this proposal may ultimately lead to a change in clinical practice for patients with SCD and targets an NCCIH strategic priority of non-pharmacologic management of pain. The PI is highly committed to performing POR focused on nutrition science and in growing her mentorship reach to include undergraduates, graduate & medical students, post-doctoral fellows & junior faculty in clinical nutrition research. The environment at Emory University is ideal to foster these goals, through partnership with the Georgia Clinical & Translational Science Alliance (CTSA). The CTSA provides additional institutional infrastructure & enriches access to mentees for the K24 applicant, who is one of 140 participating CTSA faculty.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $140,897 )
2026	2026	EMORY UNIVERSITY	201 DOWMAN DR NE	ATLANTA	GA	30322	DEKALB	USA	Research and Training in Complementary and Integrative Health	000	9	8/6/2026	NON-COMPETING CONTINUATION	$140,897
														Subtotal = $140,897

Issue Date FY: 2025 ( Subtotal = $142,159 )
2025	2025	EMORY UNIVERSITY	201 DOWMAN DR NE	ATLANTA	GA	30322	DEKALB	USA	Research and Training in Complementary and Integrative Health	000	8	8/4/2025	NON-COMPETING CONTINUATION	$142,159
														Subtotal = $142,159

Issue Date FY: 2024 ( Subtotal = $143,384 )
2024	2024	EMORY UNIVERSITY	201 DOWMAN DR NE	ATLANTA	GA	30322	DEKALB	USA	Research and Training in Complementary and Integrative Health	002	7	8/5/2024	NON-COMPETING CONTINUATION	$143,384
2024	2023	EMORY UNIVERSITY	201 DOWMAN DR NE	ATLANTA	GA	30322	DEKALB	USA	Research and Training in Complementary and Integrative Health	001	6	7/31/2024	COMPETING CONTINUATION	$46,644
2024	2022	EMORY UNIVERSITY	201 DOWMAN DR NE	ATLANTA	GA	30322	DEKALB	USA	Research and Training in Complementary and Integrative Health	000	5	7/31/2024	NON-COMPETING CONTINUATION	-$46,644
														Subtotal = $143,384

Issue Date FY: 2023 ( Subtotal = $144,573 )
2023	2023	EMORY UNIVERSITY	201 DOWMAN DR	ATLANTA	GA	30322	DEKALB	USA	Research and Training in Complementary and Integrative Health	000	6	8/9/2023	COMPETING CONTINUATION	$144,573
														Subtotal = $144,573

Issue Date FY: 2022 ( Subtotal = $177,832 )
2022	2022	EMORY UNIVERSITY	201 DOWMAN DR	ATLANTA	GA	30322	DEKALB	USA	Research and Training in Complementary and Integrative Health	000	5	6/22/2022	NON-COMPETING CONTINUATION	$177,832
														Subtotal = $177,832

Issue Date FY: 2021 ( Subtotal = $178,791 )
2021	2021	EMORY UNIVERSITY	201 DOWMAN DR	ATLANTA	GA	30322	DEKALB	USA	Research and Training in Complementary and Integrative Health	000	4	8/11/2021	NON-COMPETING CONTINUATION	$178,791
														Subtotal = $178,791

Issue Date FY: 2020 ( Subtotal = $179,750 )
2020	2020	EMORY UNIVERSITY	201 DOWMAN DR	ATLANTA	GA	30322	DEKALB	USA	Research and Training in Complementary and Integrative Health	000	3	8/3/2020	NON-COMPETING CONTINUATION	$179,750
														Subtotal = $179,750

Issue Date FY: 2019 ( Subtotal = $180,951 )
2019	2019	EMORY UNIVERSITY	1599 CLIFTON RD.	ATLANTA	GA	30322	DEKALB	USA	Research and Training in Complementary and Integrative Health	000	2	7/22/2019	NON-COMPETING CONTINUATION	$180,951
														Subtotal = $180,951

Issue Date FY: 2018 ( Subtotal = $181,867 )
2018	2018	EMORY UNIVERSITY	1599 CLIFTON RD.	ATLANTA	GA	30322	DEKALB	USA	Research and Training in Complementary and Integrative Health	000	1	9/24/2018	NEW	$181,867
														Subtotal = $181,867

Grand Total All Awards = $1,470,204

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Patient-Oriented Research in Arginine Deficiency Syndromes

Award Number: K24AT009893

ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

PERIOD OF PERFORMANCE START DATE: 09/24/2018

PERIOD OF PERFORMANCE END DATE: 07/31/2028

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