# Wake Forest Collaborative Application for an APOLLO Clinical Center

> **NIH NIH U01** · WAKE FOREST UNIVERSITY HEALTH SCIENCES · 2022 · $220,830

## Abstract

We are applying to participate as an APOLLO Clinical Center in this national prospective study. The NIH
APOL1 Long-term Transplantation Outcomes Network (APOLLO) Collaborative U01 will perform a national
prospective evaluation of donor and recipient APOL1 renal-risk variants in all U.S. kidney transplantations from
African American donors to determine their effects on transplant outcomes. In addition, the health of living
African American kidney donors will be assessed. Information that was lacking from prior retrospective studies
needs to be collected, including renal histologic data in allograft failures and presence or development of BK
viral infections, donor specific antibodies, and acute rejections after kidney transplantation. Our investigative
team, led by two PIs with complementary expertise, has led the way in clinical trials to address the marked
disparities in African Americans with end-stage kidney disease. Renal transplantations from deceased African
American kidney donors do not last as long as those from deceased European American kidney
donors. Reasons for this are unknown, but retrospective reports suggest that presence of two apolipoprotein
L1 (APOL1) gene renal-risk variants in kidney donors may contribute. These renal-risk variants are common in
populations with recent African ancestry (such as African Americans), where they are strongly associated with
non-diabetic end-stage kidney disease. In contrast, these risk variants are rare in other ethnic groups. APOL1
genotype data may prove to be clinically useful in those with recent African ancestry in the setting of allocation
of deceased donor kidneys for transplantation and assessment of prospective living kidney donors. Genotypic
information (precision medicine) may provide more accurate assessment of the likelihood for long-term renal
allograft function in donor kidneys, thereby improving the matching of donor kidneys with potential recipients to
optimize renal allograft and patient survival. Information may better inform physicians about organ quality prior
to decisions on allocation. However, before these genotypic data can be used in the clinical setting, a
prospective national study is required to evaluate kidney transplantation outcomes from African American
donors and recipients of their kidneys based on APOL1 genotypes. Information lacking from prior retrospective
studies will be collected, including renal histologic data in allograft failures and presence or development of BK
viral infections, donor specific antibodies, and acute rejections after kidney transplantation. This is the rationale
and setting for the current APOLLO trial. In this important multi-site study, our site will work closely with the
APOLLO Scientific and Data Research Center and the other participating sites to recruit and prospectively
follow eligible kidney donors and transplant recipients based on the APOLLO protocol. Results have the
potential to transform the organ allocation and informed c...

## Key facts

- **NIH application ID:** 10213701
- **Project number:** 5U01DK116040-05
- **Recipient organization:** WAKE FOREST UNIVERSITY HEALTH SCIENCES
- **Principal Investigator:** Rasheed Adebayo Gbadegesin
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $220,830
- **Award type:** 5
- **Project period:** 2017-09-25 → 2023-09-04

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10213701

## Citation

> US National Institutes of Health, RePORTER application 10213701, Wake Forest Collaborative Application for an APOLLO Clinical Center (5U01DK116040-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10213701. Licensed CC0.

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