APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO): Design and Rationale

doi:10.1016/j.ekir.2019.11.022

. 2019 Dec 13;5(3):278-288.

doi: 10.1016/j.ekir.2019.11.022. eCollection 2020 Mar.

APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO): Design and Rationale

Barry I Freedman¹, Marva M Moxey-Mims², Amir A Alexander³, Brad C Astor⁴, Kelly A Birdwell⁵, Donald W Bowden⁶, Gordon Bowen⁷, Jonathan Bromberg^{8

9}, Timothy E Craven³, Darshana M Dadhania^{10

11}, Jasmin Divers³, Mona D Doshi¹², Elling Eidbo¹³, Alessia Fornoni¹⁴, Michael D Gautreaux¹⁵, Rasheed A Gbadegesin¹⁶, Patrick O Gee¹⁷, Giselle Guerra^{14

18}, Chi-Yuan Hsu¹⁹, Ana S Iltis²⁰, Nichole Jefferson²¹, Bruce A Julian²², David K Klassen²³, Patrick P Koty²⁴, Carl D Langefeld³, Krista L Lentine²⁵, Lijun Ma¹, Roslyn B Mannon²², Madhav C Menon^{26

27}, Sumit Mohan^{28

29}, J Brian Moore³⁰, Barbara Murphy^{26

27}, Kenneth A Newell³¹, Jonah Odim³², Mariella Ortigosa-Goggins^{14

18}, Nicholette D Palmer⁶, Meyeon Park¹⁹, Afshin Parsa³³, Stephen O Pastan³⁴, Emilio D Poggio³⁵, Nishadi Rajapakse³⁶, Amber M Reeves-Daniel¹, Sylvia E Rosas^{37

38}, Laurie P Russell³, Deirdre Sawinski³⁹, S Carrie Smith⁶, Mitzie Spainhour¹, Robert J Stratta⁴⁰, Matthew R Weir⁴¹, David M Reboussin³, Paul L Kimmel³³, Daniel C Brennan⁴²

Affiliations

¹ Department of Internal Medicine, Section on Nephrology, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.
² Division of Nephrology, Children's National Health System, Washington, DC, USA.
³ Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.
⁴ Department of Medicine, Division of Nephrology, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.
⁵ Department of Medicine, Division of Nephrology and Hypertension, Vanderbilt University, Nashville, Tennessee, USA.
⁶ Department of Biochemistry, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.
⁷ Lifebanc, Cleveland, Ohio, USA.
⁸ Department of Surgery, Division of Transplantation, University of Maryland School of Medicine, Baltimore, Maryland, USA.
⁹ Department of Microbiology and Immunology, Division of Transplantation, University of Maryland School of Medicine, Baltimore, Maryland, USA.
¹⁰ Division of Nephrology, Weill Cornell Medicine, New York, New York, USA.
¹¹ Department of Transplantation Medicine, New York Presbyterian Hospital, New York, New York, USA.
¹² Division of Nephrology, University of Michigan School of Medicine, Ann Arbor, Michigan, USA.
¹³ Association of Organ Procurement Organizations, Vienna, Virginia, USA.
¹⁴ Katz Family Division of Nephrology and Hypertension, Peggy and Harold Katz Drug Discovery Center, University of Miami Miller School of Medicine, Miami, Florida, USA.
¹⁵ Human Leukocyte Antigen/Immunogenetics and Immunodiagnostics Laboratories, Department of Pathology, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.
¹⁶ Department of Pediatrics, Division of Nephrology, Duke University School of Medicine, Durham, North Carolina, USA.
¹⁷ APOLLO Community Advisory Council, Cleveland Clinic, Cleveland, Ohio, USA.
¹⁸ Miami Transplant Institute, University of Miami Miller School of Medicine, Miami, Florida, USA.
¹⁹ Department of Medicine, Division of Nephrology, University of California, San Francisco, San Francisco, California, USA.
²⁰ Center for Bioethics, Health and Society, Department of Philosophy, Wake Forest University, Winston-Salem, North Carolina, USA.
²¹ APOLLO Steering Committee, APOLLO Community Advisory Council, Dallas, Texas, USA.
²² Department of Medicine, Division of Nephrology, University of Alabama School of Medicine in Birmingham, Birmingham, Alabama, USA.
²³ United Network for Organ Sharing, Office of the Chief Medical Officer, Richmond, Virginia, USA.
²⁴ Department of Pathology, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.
²⁵ Department of Medicine, Center for Abdominal Transplantation, Saint Louis University School of Medicine, St. Louis, Missouri, USA.
²⁶ Department of Nephrology, Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
²⁷ Recanati-Miller Transplant Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
²⁸ Division of Nephrology, Department of Medicine, Vagelos College of Physicians & Surgeons, Columbia University, New York, New York, USA.
²⁹ Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, New York, USA.
³⁰ Institutional Review Board, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.
³¹ Department of Surgery, Division of Transplantation, Emory University School of Medicine, Atlanta, Georgia, USA.
³² Transplantation Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
³³ Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland, USA.
³⁴ Department of Medicine, Renal Division, Emory University School of Medicine, Atlanta, Georgia, USA.
³⁵ Department of Nephrology and Hypertension, Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, Ohio, USA.
³⁶ National Institutes of Health, National Institute on Minority Health and Health Disparities, Division of Scientific Programs, Bethesda, Maryland, USA.
³⁷ Kidney and Hypertension Unit, Joslin Diabetes Center and Harvard Medical School, Boston, Massachusetts, USA.
³⁸ Division of Nephrology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
³⁹ Renal Electrolyte and Hypertension Division, Department of Medicine, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
⁴⁰ Department of Surgery, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.
⁴¹ Department of Medicine, Division of Nephrology, University of Maryland School of Medicine, Baltimore, Maryland, USA.
⁴² Division of Nephrology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.

PMID: 32154449
PMCID: PMC7056919
DOI: 10.1016/j.ekir.2019.11.022

APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO): Design and Rationale

Barry I Freedman et al. Kidney Int Rep. 2019.

. 2019 Dec 13;5(3):278-288.

doi: 10.1016/j.ekir.2019.11.022. eCollection 2020 Mar.

Authors

Affiliations

¹ Department of Internal Medicine, Section on Nephrology, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.
² Division of Nephrology, Children's National Health System, Washington, DC, USA.
³ Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.
⁴ Department of Medicine, Division of Nephrology, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.
⁵ Department of Medicine, Division of Nephrology and Hypertension, Vanderbilt University, Nashville, Tennessee, USA.
⁶ Department of Biochemistry, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.
⁷ Lifebanc, Cleveland, Ohio, USA.
⁸ Department of Surgery, Division of Transplantation, University of Maryland School of Medicine, Baltimore, Maryland, USA.
⁹ Department of Microbiology and Immunology, Division of Transplantation, University of Maryland School of Medicine, Baltimore, Maryland, USA.
¹⁰ Division of Nephrology, Weill Cornell Medicine, New York, New York, USA.
¹¹ Department of Transplantation Medicine, New York Presbyterian Hospital, New York, New York, USA.
¹² Division of Nephrology, University of Michigan School of Medicine, Ann Arbor, Michigan, USA.
¹³ Association of Organ Procurement Organizations, Vienna, Virginia, USA.
¹⁴ Katz Family Division of Nephrology and Hypertension, Peggy and Harold Katz Drug Discovery Center, University of Miami Miller School of Medicine, Miami, Florida, USA.
¹⁵ Human Leukocyte Antigen/Immunogenetics and Immunodiagnostics Laboratories, Department of Pathology, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.
¹⁶ Department of Pediatrics, Division of Nephrology, Duke University School of Medicine, Durham, North Carolina, USA.
¹⁷ APOLLO Community Advisory Council, Cleveland Clinic, Cleveland, Ohio, USA.
¹⁸ Miami Transplant Institute, University of Miami Miller School of Medicine, Miami, Florida, USA.
¹⁹ Department of Medicine, Division of Nephrology, University of California, San Francisco, San Francisco, California, USA.
²⁰ Center for Bioethics, Health and Society, Department of Philosophy, Wake Forest University, Winston-Salem, North Carolina, USA.
²¹ APOLLO Steering Committee, APOLLO Community Advisory Council, Dallas, Texas, USA.
²² Department of Medicine, Division of Nephrology, University of Alabama School of Medicine in Birmingham, Birmingham, Alabama, USA.
²³ United Network for Organ Sharing, Office of the Chief Medical Officer, Richmond, Virginia, USA.
²⁴ Department of Pathology, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.
²⁵ Department of Medicine, Center for Abdominal Transplantation, Saint Louis University School of Medicine, St. Louis, Missouri, USA.
²⁶ Department of Nephrology, Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
²⁷ Recanati-Miller Transplant Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
²⁸ Division of Nephrology, Department of Medicine, Vagelos College of Physicians & Surgeons, Columbia University, New York, New York, USA.
²⁹ Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, New York, USA.
³⁰ Institutional Review Board, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.
³¹ Department of Surgery, Division of Transplantation, Emory University School of Medicine, Atlanta, Georgia, USA.
³² Transplantation Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
³³ Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland, USA.
³⁴ Department of Medicine, Renal Division, Emory University School of Medicine, Atlanta, Georgia, USA.
³⁵ Department of Nephrology and Hypertension, Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, Ohio, USA.
³⁶ National Institutes of Health, National Institute on Minority Health and Health Disparities, Division of Scientific Programs, Bethesda, Maryland, USA.
³⁷ Kidney and Hypertension Unit, Joslin Diabetes Center and Harvard Medical School, Boston, Massachusetts, USA.
³⁸ Division of Nephrology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
³⁹ Renal Electrolyte and Hypertension Division, Department of Medicine, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
⁴⁰ Department of Surgery, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.
⁴¹ Department of Medicine, Division of Nephrology, University of Maryland School of Medicine, Baltimore, Maryland, USA.
⁴² Division of Nephrology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.

PMID: 32154449
PMCID: PMC7056919
DOI: 10.1016/j.ekir.2019.11.022

Abstract

Introduction: Much of the higher risk for end-stage kidney disease (ESKD) in African American individuals relates to ancestry-specific variation in the apolipoprotein L1 gene (APOL1). Relative to kidneys from European American deceased-donors, kidneys from African American deceased-donors have shorter allograft survival and African American living-kidney donors more often develop ESKD. The National Institutes of Health (NIH)-sponsored APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) is prospectively assessing kidney allograft survival from donors with recent African ancestry based on donor and recipient APOL1 genotypes.

Methods: APOLLO will evaluate outcomes from 2614 deceased kidney donor-recipient pairs, as well as additional living-kidney donor-recipient pairs and unpaired deceased-donor kidneys.

Results: The United Network for Organ Sharing (UNOS), Association of Organ Procurement Organizations, American Society of Transplantation, American Society for Histocompatibility and Immunogenetics, and nearly all U.S. kidney transplant programs, organ procurement organizations (OPOs), and histocompatibility laboratories are participating in this observational study. APOLLO employs a central institutional review board (cIRB) and maintains voluntary partnerships with OPOs and histocompatibility laboratories. A Community Advisory Council composed of African American individuals with a personal or family history of kidney disease has advised the NIH Project Office and Steering Committee since inception. UNOS is providing data for outcome analyses.

Conclusion: This article describes unique aspects of the protocol, design, and performance of APOLLO. Results will guide use of APOL1 genotypic data to improve the assessment of quality in deceased-donor kidneys and could increase numbers of transplanted kidneys, reduce rates of discard, and improve the safety of living-kidney donation.

Keywords: APOL1; African Americans; chronic kidney disease; graft failure; kidney transplantation; outcomes.

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Figures

**Figure 1**
*APOL1* Long-term Kidney Transplantation Outcomes Network (APOLLO) organizational chart (developed using clker.com free clipart; http://www.clker.com/clipart-blank-gray-usa-map-white-lines-1.html). NIH, National Institutes of Health; OPO, organ procurement organization.

See this image and copyright information in PMC

Comment in

Launching APOLLO: The Role of APOL1 Genetic Variants in Live- and Deceased-Donor Kidney Transplantation.
Fuentes F, Kopp JB. Fuentes F, et al. Kidney Int Rep. 2019 Dec 27;5(3):252-254. doi: 10.1016/j.ekir.2019.12.014. eCollection 2020 Mar. Kidney Int Rep. 2019. PMID: 32154807 Free PMC article. No abstract available.

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References

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[1] Israni A.K., Salkowski N., Gustafson S. New national allocation policy for deceased donor kidneys in the United States and possible effect on patient outcomes. J Am Soc Nephrol. 2014;25:1842–1848. - PMC - PubMed

[2] Israni A.K., Salkowski N., Gustafson S. New national allocation policy for deceased donor kidneys in the United States and possible effect on patient outcomes. J Am Soc Nephrol. 2014;25:1842–1848. - PMC - PubMed

[3] Rao P.S., Schaubel D.E., Guidinger M.K. A comprehensive risk quantification score for deceased donor kidneys: the kidney donor risk index. Transplantation. 2009;88:231–236. - PubMed

[4] Rao P.S., Schaubel D.E., Guidinger M.K. A comprehensive risk quantification score for deceased donor kidneys: the kidney donor risk index. Transplantation. 2009;88:231–236. - PubMed

[5] Genovese G., Friedman D.J., Ross M.D. Association of trypanolytic ApoL1 variants with kidney disease in African Americans. Science. 2010;329:841–845. - PMC - PubMed

[6] Genovese G., Friedman D.J., Ross M.D. Association of trypanolytic ApoL1 variants with kidney disease in African Americans. Science. 2010;329:841–845. - PMC - PubMed

[7] Tzur S., Rosset S., Shemer R. Missense mutations in the APOL1 gene are highly associated with end stage kidney disease risk previously attributed to the MYH9 gene. Hum Genet. 2010;128:345–350. - PMC - PubMed

[8] Tzur S., Rosset S., Shemer R. Missense mutations in the APOL1 gene are highly associated with end stage kidney disease risk previously attributed to the MYH9 gene. Hum Genet. 2010;128:345–350. - PMC - PubMed

[9] Freedman B.I., Limou S., Ma L. APOL1-associated nephropathy: a key contributor to racial disparities in CKD. Am J Kidney Dis. 2018;72:S8–S16. - PMC - PubMed

[10] Freedman B.I., Limou S., Ma L. APOL1-associated nephropathy: a key contributor to racial disparities in CKD. Am J Kidney Dis. 2018;72:S8–S16. - PMC - PubMed

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APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO): Design and Rationale

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APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO): Design and Rationale

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