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Long-term Kidney Transplantation Outcomes Network (APOLLO) Clinical Center

Award Number: U01DK116093
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: 09/25/2017
PERIOD OF PERFORMANCE END DATE: 05/31/2028

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Long-term Kidney Transplantation Outcomes Network (APOLLO) Clinical Center - An excess burden of chronic kidney and end stage renal disease is experienced by Black Americans. Risk variants in the apolipoprotein-1 (APOL1) gene, found almost exclusively in individuals of African ancestry, are associated with several forms of non-diabetic kidney disease in Black Americans, including focal segmental glomerulosclerosis, HIV-associated nephropathy, and hypertension-related kidney disease. These APOL1 risk variants explain up to 70% of the excess risk in Black Americans with these kidney diseases. However, presence of these risk variants does not guarantee development of kidney disease, with secondary genetic or environmental hits required. This along with lack of targeted therapies makes the value of genetic screening for APOL1 risk variants unknown. The impact of APOL1 risk variants in kidney transplantation, for both donors and recipients, is understudied. It is unknown if living kidney donors with APOL1 risk variants are at increased risk for development of kidney disease post donation. For recipients, initial studies have suggested that recipients who receive donor kidneys with two APOL1 risk variants may have worse graft outcomes. Due to both biological and social-economic factors, Black Americans have been historically disadvantaged in receiving kidney transplants, and the theoretical practice of APOL1 genetic screening and excluding donors with risk variants could further disadvantage this population. These multiple questions highlight the need to thoroughly examine the impact of APOL1 risk alleles on transplant outcomes. The NIH- sponsored APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) is addressing this important question by uniting transplant centers, organ procurement organizations (OPOs), and the United Network for Organ Sharing (UNOS) to enroll donors of African ancestry and their kidney recipients, then follow their transplant outcomes. In Phase 1 of APOLLO, we have functioned as an ideal clinical center in direct response to original request for application by enrolling 154 qualifying deceased donor recipients, living donors, and living donor recipients through partnerships with 8 transplant centers in addition to our primary Vanderbilt University Medical Clinical Center, providing DNA, biospecimens, and essential longitudinal clinical data. Our aligned transplant centers include large academic programs as well a small community programs to strive for the goal of universal enrollment. We have worked seamlessly with the other Clinical Centers and the SDRC, as well as partnered with OPOs and UNOS, to build a strong foundation for APOLLO. For Phase 2, we will continue the important work of the APOLLO Consortium through accomplishment of several aims. In Aim 1, we will prospectively collect long-term follow-up data on all APOLLO participants and enroll additional living donors. In Aim 2, we will provide detailed clinical data and biospecimens on APOLLO participants as well as kidney transplant biopsy slides from our Clinical Center. In Aim 3, we will facilitate return of APOL1 genotype results. Once completed, these Aims will advance our knowledge of APOL1 in kidney transplantation.


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: 2025 ( Subtotal = $217,380 )
2025	2025	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	8	7/14/2025	NON-COMPETING CONTINUATION	$217,380
2025	2024	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	7	1/7/2025	NON-COMPETING CONTINUATION	$0
2025	2023	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	6	1/27/2025	COMPETING CONTINUATION	$39,069
2025	2022	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	5	1/27/2025	NON-COMPETING CONTINUATION	-$39,069
														Subtotal = $217,380

Issue Date FY: 2024 ( Subtotal = $215,000 )
2024	2024	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	7	7/2/2024	NON-COMPETING CONTINUATION	$215,000
														Subtotal = $215,000

Issue Date FY: 2023 ( Subtotal = $333,017 )
2023	2023	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	6	9/6/2023	COMPETING CONTINUATION	$333,017
														Subtotal = $333,017

Issue Date FY: 2022 ( Subtotal = $306,448 )
2022	2022	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	5	7/7/2022	NON-COMPETING CONTINUATION	$306,448
2022	2020	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	12/7/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $306,448

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	4	8/31/2021	NON-COMPETING CONTINUATION	$0
2021	2020	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	3/9/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $133,332 )
2020	2020	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	4	7/8/2020	NON-COMPETING CONTINUATION	$133,332
2020	2019	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	3/16/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $133,332

Issue Date FY: 2019 ( Subtotal = $346,140 )
2019	2019	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	7/8/2019	NON-COMPETING CONTINUATION	$346,140
														Subtotal = $346,140

Issue Date FY: 2018 ( Subtotal = $354,675 )
2018	2018	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	9/10/2018	SUPPLEMENT FOR EXPANSION	$84,825
2018	2018	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	8/22/2018	NON-COMPETING CONTINUATION	$269,850
														Subtotal = $354,675

Issue Date FY: 2017 ( Subtotal = $282,822 )
2017	2017	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/15/2017	NEW	$282,822
														Subtotal = $282,822

Grand Total All Awards = $2,188,814

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Long-term Kidney Transplantation Outcomes Network (APOLLO) Clinical Center

Award Number: U01DK116093

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: 09/25/2017

PERIOD OF PERFORMANCE END DATE: 05/31/2028

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