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4/14 APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) Clinical Center

Award Number: U01DK115997
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Abstract Kidneys from deceased African American donors have reduced allograft survival compared to kidneys from donors from European Americans. Likewise, kidneys from deceased donors with 2 apolipoprotein L1 gene (APOL1) renal-risk variants, defined as APOL1 high-risk genotypes, have shorter allograft survival. Importantly, many kidneys transplanted from deceased donors with 2 APOL1 risk variants do not fail rapidly. We postulate that APOL1 interacts with other environmental or inherited factors to accelerate the failure of kidneys transplanted from deceased donors. APOL1 renal-risk variants are almost exclusively in individuals of recent African ancestry. Relative differences in the prevalence of blood types and human leukocyte antigens lead to more kidneys from deceased African American donors being allocated to African Americans, potentially exacerbating disparities in transplant outcomes. African American living kidney donors face a greater risk of post-donation kidney failure compared to White living donors, but including APOL1 genotyping in the evaluation and selection of African American donors remains controversial. The National Institutes of Health established the “APOL1 Long-term Kidney Transplantation Outcomes” (APOLLO) Consortium in 2017 to prospectively address several critical questions regarding the broad implementation of APOL1 genotyping in kidney transplantation and to assess its role in the evaluation of living donors. APOLLO assesses factors determining time to allograft failure (primary outcome), post-transplant kidney function and proteinuria (secondary outcomes) in kidneys from donors with recent African ancestry. The APOLLO Consortium includes a Scientific and Data Research Center (SDRC) and 13 Clinical Centers, including our Center with 8 kidney transplant programs, encompassing high-volume and smaller programs with diverse practice patterns and geographic representation. Through 9/29/22, APOLLO, in its initial phase, has prospectively collected DNA from 3604 deceased donors and is following outcomes for the 4890 recipients. APOLLO has collected DNA from 2436 recipients of whom Clinical Center 04 (CC04) has enrolled 17.1% (417). CC04 also recruited 7% (15) of the APOLLO living donors and their recipients. In the proposed APOLLO Phase 2 study, we will prospectively collect long-term follow-up data and measure urine albumin to creatinine ratio > 2 years after transplantation for all APOLLO Phase 1 participants. For those at the University of Alabama at Birmingham, we will provide detailed clinical data, collect biospecimens (blood and urine after 1st post-transplant year), and collect slides from all allograft biopsies for APOLLO Digital Pathology Repository. Working with the SDRC, CC04 will return APOL1 genotype results to recipients and living donors at our aligned transplant programs. The results from this national study have the potential to transform organ allocation and informed-consent processes for the transplantation of kidneys from donors with recent African ancestry, improve kidney allograft survival, and elucidate the mechanisms whereby APOL1 renal-risk variants produce kidney disease.


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: 2024 ( Subtotal = $310,000 )
2024	2024	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	7	7/11/2024	NON-COMPETING CONTINUATION	$310,000
2024	2023	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	6	2/23/2024	COMPETING CONTINUATION	$92,242
2024	2022	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	2/23/2024	NON-COMPETING CONTINUATION	-$92,242
														Subtotal = $310,000

Issue Date FY: 2023 ( Subtotal = $280,127 )
2023	2023	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	6	8/31/2023	COMPETING CONTINUATION	$280,127
2023	2022	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	5	8/22/2023	NON-COMPETING CONTINUATION	$0
2023	2022	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	5	6/26/2023	NON-COMPETING CONTINUATION	$0
2023	2022	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	4/4/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $280,127

Issue Date FY: 2022 ( Subtotal = $306,450 )
2022	2022	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	5	7/6/2022	NON-COMPETING CONTINUATION	$306,450
2022	2022	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	5	8/19/2022	NON-COMPETING CONTINUATION	$0
2022	2020	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	4	3/7/2022	NON-COMPETING CONTINUATION	$0
2022	2020	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	11/9/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $306,450

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	9/1/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $133,332 )
2020	2020	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	4	7/10/2020	NON-COMPETING CONTINUATION	$133,332
2020	2019	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	3/5/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $133,332

Issue Date FY: 2019 ( Subtotal = $346,141 )
2019	2019	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	3	7/10/2019	NON-COMPETING CONTINUATION	$346,141
2019	2018	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	7/9/2019	NON-COMPETING CONTINUATION	$0
2019	2018	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	12/4/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $346,141

Issue Date FY: 2018 ( Subtotal = $354,676 )
2018	2018	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	9/10/2018	SUPPLEMENT FOR EXPANSION	$84,826
2018	2018	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	8/22/2018	NON-COMPETING CONTINUATION	$269,850
														Subtotal = $354,676

Issue Date FY: 2017 ( Subtotal = $277,820 )
2017	2017	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/18/2017	NEW	$277,820
														Subtotal = $277,820

Grand Total All Awards = $2,008,546

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4/14 APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) Clinical Center

Award Number: U01DK115997

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

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