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1-13 ApoL1 Genotypes in Kidney Donors and Long-Term Outcomes in Kidney Transplant Recipients Clinical Center

Award Number: U01DK116101
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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1-13 ApoL1 Genotypes in Kidney Donors and Long-Term Outcomes in Kidney Transplant Recipients Clinical Center - PROJECT SUMMARY APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) Clinical Center We submit this application in response to RFA-DK-22-506. The University of Miami, Miami Transplant Institute, Jackson Memorial Hospital is the Clinical Center 11 which is a current member of the APOLLO Consortium. This Consortium was established in 2017 to work seamlessly with the Association of Organ Procurement Organizations (AOPO) to enroll participants in the largest observational study to date of kidney transplant recipients and donors to evaluate APOL1 gene mutations in kidney donor as a risk factor for graft loss. Our Clinical Center has been a leader and top enroller for eligible recipients and living kidney donors in the state of Florida, Puerto Rico and 2 transplant centers in California. This has been achieved through a very close collaboration between all site PIs and research coordinators. The following transplant centers are part of CC11: participating as engaged centers are: The Miami Transplant Institute, Tampa General Hospital, Mayo Clinic Jacksonville, the University of Florida; participating as non-engaged centers are: Advent Health Orlando Florida, Memorial Healthcare System Broward Hospital Florida, Auxilio Mutuo Hospital in Puerto Rico, California Institute of Renal Research and University of California, Irvine. In Phase 1 of APOLLO, we have successfully consented 241 kidney transplant recipients and 20 living donors, with DNA on hand in 220 recipients (91%) and 20 donors (100%), across all centers. Our site has overseen the careful collection of clinical data from the electronic medical record at our own site and subsites to complete the APOLLO Consortium Data Forms accurately and entirely, with 97% to 100% of the data entry at various data points. In Phase 2, we will continue to obtain critical follow-up data on all participants and ensure completion of data abstraction from electronic medical record, to provide patient-level detail not available in databases maintained by United Network for Organ Sharing (UNOS) and the Scientific Registry of Transplant Recipients (SRTR). We will ensure a urine albumin-to-creatinine ratio is measured in all participants, at all sites, at a longitudinal follow-up time point of at least two years from original enrollment in APOLLO Phase 1. The University of Miami, Miami Transplant Institute, will continue to collect additional biospecimens for contribution to the biorepository as well as unstained biopsy slides as we have been doing through Phase 1. We will work with the Scientific Data and Research Center (SDRC) to ensure return of genotype results to all participants who desire this information. We will also continue to recruit living donors at the Miami Transplant Institute. Continuation of the APOLLO Consortium will lead to important advances in our understanding of APOL1 high-risk status and its influence on graft function as well as the biology of APOL1 gene effects.


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 = $262,377 )
2025	2025	UNIVERSITY OF MIAMI	1320 S DIXIE HWY STE 1200	CORAL GABLES	FL	33146	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	8	7/14/2025	NON-COMPETING CONTINUATION	$262,377
														Subtotal = $262,377

Issue Date FY: 2024 ( Subtotal = $260,000 )
2024	2024	UNIVERSITY OF MIAMI	1320 S DIXIE HWY STE 1200	CORAL GABLES	FL	33146	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	7	7/11/2024	NON-COMPETING CONTINUATION	$260,000
2024	2023	UNIVERSITY OF MIAMI	1320 S DIXIE HWY STE 1200	CORAL GABLES	FL	33146	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	6	4/16/2024	COMPETING CONTINUATION	$13,031
2024	2022	UNIVERSITY OF MIAMI	1320 S DIXIE HWY STE 1200	CORAL GABLES	FL	33146	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	4/16/2024	NON-COMPETING CONTINUATION	-$13,031
														Subtotal = $260,000

Issue Date FY: 2023 ( Subtotal = $351,400 )
2023	2023	UNIVERSITY OF MIAMI	1400 NW 10TH AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	6	8/31/2023	COMPETING CONTINUATION	$351,400
														Subtotal = $351,400

Issue Date FY: 2022 ( Subtotal = $303,659 )
2022	2022	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	5	7/7/2022	NON-COMPETING CONTINUATION	$303,659
2022	2020	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	11/9/2021	NON-COMPETING CONTINUATION	$0
2022	2020	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	4	3/10/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $303,659

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	8/31/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $133,334 )
2020	2020	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	7/14/2020	NON-COMPETING CONTINUATION	$133,334
														Subtotal = $133,334

Issue Date FY: 2019 ( Subtotal = $343,356 )
2019	2019	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	7/9/2019	NON-COMPETING CONTINUATION	$343,356
2019	2018	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	7/8/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $343,356

Issue Date FY: 2018 ( Subtotal = $351,891 )
2018	2018	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	9/11/2018	SUPPLEMENT FOR EXPANSION	$84,826
2018	2018	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	9/7/2018	NON-COMPETING CONTINUATION	$267,065
														Subtotal = $351,891

Issue Date FY: 2017 ( Subtotal = $276,819 )
2017	2017	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/15/2017	NEW	$276,819
														Subtotal = $276,819

Grand Total All Awards = $2,282,836

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1-13 ApoL1 Genotypes in Kidney Donors and Long-Term Outcomes in Kidney Transplant Recipients Clinical Center

Award Number: U01DK116101

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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