# Studying APOL1 Following Transplantation (SAF-T): the Emory APOLLO Clinical Center Consortium

> **NIH NIH U01** · EMORY UNIVERSITY · 2020 · $133,332

## Abstract

Summary/Abstract
Data demonstrate that transplanted kidneys from African American (AA) deceased donors are associated with
reduced survival relative to kidneys from non-AA donors. Additional data demonstrate that the presence of two
APOL1 risk variants, that are found exclusively in AA individuals, have been associated with an increased risk
of CKD/ESRD in the general AA population. Two risk variants of this gene have a prevalence of 13% in AAs,
and may account for some or all of the increased risk of transplant loss. There are also anecdotal reports of AA
living kidney donors with two APOL1 risk variants developing ESRD raising further concerns. The APOLLO
study proposes to enroll all deceased and living AA kidney donors in order to definitively address the impact of
APOL1 variants on kidney transplant outcomes. The Emory APOLLO Clinical Centers consortium is comprised
of 12 centers distributed across the US but focused in the Southeast. In 2015 these 12 programs transplanted
219 kidneys from deceased and living AA donors accounting for about 9% of all recipients of AA kidneys, the
eligible study cohort in the US. The specific aims of our consortium are: (1) to perform APOL1 genotyping on
all AA deceased and living kidney donors and create a sample repository for future studies to determine
whether additional genetic factors contribute to the second hit postulated to be required for risk manifestation,
(2) to compare the survival and function of all transplanted kidneys from AA donors to determine the impact of
two APOL1 risk variants on transplant outcomes as well as exploring the potential of environmental factors
(rejection, infections, comorbid conditions such as hypertension) to provide the second hit, and 3) to study
whether African American living donors who carry two copies of the variant APOL1 genes are at increased risk
for chronic kidney disease. Blood samples for APOL1 genotyping of deceased donors will be provided by the
organ procurement organization, while the transplant centers will provide blood for genotyping recipients and
living donors (as well as deceased donors when necessary). Demographic and clinical donor and recipient
data will be provided by UNOS for all subjects. More granular clinical data will be provided for patients
receiving their long-term follow up from one the 12 participating transplant centers. We propose enrolling
subjects for 1 year and following them for 3 years thereby maximizing the likelihood of observing clinical
events. The primary outcome measure for recipients of deceased donor kidneys is graft survival with
secondary outcome measures assessing a variety of indicators of renal function and injury. As advance CKD
or ESRD following living kidney donation are highly unlikely events, given the relatively short study duration the
primary outcome for living kidney donors will be the change in renal function from the post-transplant baseline
to the end of follow up at 3 years post-donation. When combined ...

## Key facts

- **NIH application ID:** 9975005
- **Project number:** 5U01DK116099-04
- **Recipient organization:** EMORY UNIVERSITY
- **Principal Investigator:** KENNETH A. NEWELL
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $133,332
- **Award type:** 5
- **Project period:** 2017-09-25 → 2023-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9975005

## Citation

> US National Institutes of Health, RePORTER application 9975005, Studying APOL1 Following Transplantation (SAF-T): the Emory APOLLO Clinical Center Consortium (5U01DK116099-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9975005. Licensed CC0.

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