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Phosphate binder therapy and chronic kidney disease in children

Award Number: U01DK122013
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/15/2020
PERIOD OF PERFORMANCE END DATE: 04/30/2029

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Phosphate binder therapy and chronic kidney disease in children - PROJECT SUMMARY/ABSTRACT The FIT4KiD (Ferric Citrate and Chronic Kidney Disease in Children) is a 12-month randomized, double-blind, placebo-controlled, multi-center trial that is assessing the effects of ferric citrate on changes in plasma intact FGF23 (iFGF23) levels over 12 months in 160 pediatric patients aged 6-18 years with chronic kidney disease (CKD) stages 3–4 and age-appropriate normal serum phosphate levels. The UCLA Data Coordinating and Clinical Coordinating Centers began extensive preparatory work for the FIT4KiD trial in 2020. Due to delays related to COVID-19 pandemic, we randomized the first patient in June 2022. We initially opened recruitment at 11 sites. By February 28, 2025, we randomized 99 participants (62% of total sample size) and onboarded additional sites to a total of 18 US and 2 Canadian sites. We are submitting this renewal application to finish the study, analyze and report the results and share data and samples with the larger scientific community. In Aim 1, to be conducted in year 1, we will complete recruitment to a total sample size of 160 randomized participants. Based on lessons learned during our first phase of funding, we developed a multi-level framework for recruitment that addresses key issues regarding capability, opportunity and motivation of site teams and patients to engage in research and incorporates an iterative process of continually monitoring recruitment success. We will employ the following strategies: educate faculty at each site on lifelong complications of CKD and need for FIT4KiD trial; leverage our clinical trial workforce readiness program that we developed during the first phase of funding; solicit input from patients and families in collaboration with Family Partners; lower participation barriers with virtual visits, transportation assistance and home health sample collection; collaborate with Recruitment Committee to closely monitor, evaluate and revise recruitment strategies. In Aim 2, to be conducted in years 1-2, we will collect high quality longitudinal follow up data and assure high levels of retention and adherence. We will continue to work with study sites to ensure that the protocol is followed with high fidelity, that data and samples are collected with high quality, and that best practices are implemented to assure high rates of retention and adherence. We will review reports summarizing retention, adherence, data completeness/quality, and safety data and hold meetings with coordinators, Executive and Steering Committees, and Data and Safety Monitoring Board. In Aim 3, to be conducting in year 3, we will analyze and report the results and share data and samples. Our primary objectives are to determine the efficacy of ferric citrate to lower iFGF23 levels in pediatric patients with CKD stages 3–4 over 12 months and to determine safety and tolerability of ferric citrate. Secondary objectives are to examine effects of ferric citrate on anemia, kidney function and indices of mineral and bone metabolism. If our hypotheses are confirmed, a new paradigm shift will emerge, in which ferric citrate would be used as first-line drug rather than current treatment using calcitriol and erythropoietin stimulating agents, which further increase the levels of FGF23.


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 = $761,975 )
2026	2026	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	6	5/8/2026	COMPETING CONTINUATION	$761,975
														Subtotal = $761,975

Issue Date FY: 2025 ( Subtotal = $1,991,014 )
2025	2025	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	5	8/4/2025	SUPPLEMENT FOR EXPANSION	$83,625
2025	2025	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	7/30/2025	NON-COMPETING CONTINUATION	$1,823,764
2025	2025	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	5	8/1/2025	SUPPLEMENT FOR EXPANSION	$83,625
														Subtotal = $1,991,014

Issue Date FY: 2024 ( Subtotal = $1,913,586 )
2024	2024	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	4	6/13/2024	NON-COMPETING CONTINUATION	$0
2024	2024	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	5/24/2024	NON-COMPETING CONTINUATION	$1,913,586
														Subtotal = $1,913,586

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	5/12/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $1,999,999 )
2022	2022	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	4/27/2022	NON-COMPETING CONTINUATION	$1,999,999
2022	2021	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	4/29/2022	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $1,999,999

Issue Date FY: 2021 ( Subtotal = $2,024,822 )
2021	2021	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	2	9/2/2021	SUPPLEMENT FOR EXPANSION	$24,999
2021	2021	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90095	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	2	4/28/2021	NON-COMPETING CONTINUATION	$0
2021	2021	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90095	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	4/14/2021	NON-COMPETING CONTINUATION	$1,999,823
2021	2020	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90095	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	4/13/2021	NEW	$0
														Subtotal = $2,024,822

Issue Date FY: 2020 ( Subtotal = $1,999,999 )
2020	2020	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90095	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	6/9/2020	NEW	$1,999,999
														Subtotal = $1,999,999

Grand Total All Awards = $10,691,395

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Phosphate binder therapy and chronic kidney disease in children

Award Number: U01DK122013

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 06/15/2020

PERIOD OF PERFORMANCE END DATE: 04/30/2029

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