NCT03615235|Active Not RecruitingDMC
APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO)
APOLLO
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APOLLO
Sponsor study identifier
Secondary identifiers
NIH
NIH
observational
5,000
1 country
18
Study Start
March 21, 2019
Actual (reported)Primary Completion
May 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The APOLLO study is being done in an attempt to improve outcomes after kidney transplantation and to improve the safety of living kidney donation based upon variation in the apolipoprotein L1 gene (APOL1). Genes control what is inherited from a family, such as eye color or blood type. Variation in APOL1 can cause kidney disease. African Americans, Afro-Caribbeans, Hispanic Blacks, and Africans are more likely to have the APOL1 gene variants that cause kidney disease. APOLLO will test DNA from kidney donors and recipients of kidney transplants for APOL1 to determine effects on kidney transplant-related outcomes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 30, 2018
Actual (reported)August 3, 2018
Actual (reported)March 21, 2019
Actual (reported)May 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Time to death-censored renal allograft failure from the UNOS database
Time from receipt of kidney transplant to death-censored renal allograft failure. Measured in days.
up to 4.5 years
The rate of loss of renal clearance function from clinical laboratory data
up to 4.5 years
The rate of change in serum creatinine concentration from clinical laboratory data
up to 4.5 years
APOLLO will prospectively assess transplant outcomes in recipients of kidneys from eligible living and deceased donors at all transplant programs in the United States including Puerto Rico.
APOLLO will prospectively assess post-donation renal outcomes in eligible living kidney donors at all transplant programs in the United States including Puerto Rico.
Thirteen APOLLO Clinical Centers (CCs) will prospectively enroll eligible living kidney donors and recipients of kidney transplants from eligible living and deceased kidney donors at all transplant programs in the continental United States including Puerto Rico. The APOLLO Scientific and Data Research Center (SDRC or Coordinating Center) will support and participate in studies determining the impact of donor and recipient APOL1 genotypes on kidney transplant outcomes in recipients of a kidney transplant from a donor with recent African ancestry, and follow African ancestry living kidney donors for changes in vital status, kidney function and proteinuria. In this protocol, recent African ancestry is broadly defined as African American, Afro-Caribbean, Hispanic black, and African.
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
University of California San Francisco
San Francisco, California, 94143, United States
University of Miami / Miami Transplant Institute
Miami, Florida, 33133, United States
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
Johns Hopkins University
Baltimore, Maryland, 21205, United States
Joslin Diabetes Center / Harvard University
Freedman BI, Moxey-Mims M. The APOL1 Long-Term Kidney Transplantation Outcomes Network-APOLLO. Clin J Am Soc Nephrol. 2018 Jun 7;13(6):940-942. doi: 10.2215/CJN.01510218. Epub 2018 Apr 27. No abstract available.
Freedman BI, Julian BA. Evaluation of Potential Living Kidney Donors in the APOL1 Era. J Am Soc Nephrol. 2018 Apr;29(4):1079-1081. doi: 10.1681/ASN.2018020137. Epub 2018 Mar 9. No abstract available.
Whole blood for DNA extraction, serum, urine, kidney biopsy samples.
Barry I. Freedman, MD
Wake Forest University Health Sciences
David M. Reboussin, PhD
Wake Forest University Health Sciences
Paul L. Kimmel, MD
Natl Institute of Diabetes, Digestive & Kidney Diseases
Marva Moxey-Mims, MD
Children's Natl Health System; George Washington Univ Sch of Med and Health Serv
First Submitted
July 30, 2018
First Posted
August 3, 2018
Study Start
March 21, 2019
Actual (reported)Primary Completion
May 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
ACTH Treatment of APOL1- Associated Nephropathy
Time to sustained development of overt proteinuria in the outpatient setting.
up to 4.5 years
Rate of change in kidney function and quantitative proteinuria from baseline pre-donation levels in living kidney donors (to include effects on stages of CKD)
up to 4.5 years
Renal allograft failure in patients with End Stage Renal Disease defined based on Standardized Outcomes in Nephrology (SONG) criteria
up to 4.5 years
Contact the study team to confirm eligibility.
Boston, Massachusetts, 02215, United States
University of Michigan Medicine
Ann Arbor, Michigan, 48109, United States
Saint Louis University Center for Transplantation
St Louis, Missouri, 63104, United States
Ichan School of Medicine at Mount Sinai
New York, New York, 10029, United States
Columbia University Irving Medical Center
New York, New York, 10032, United States
Weill Cornell Medicine
New York, New York, 10065, United States
Duke University
Durham, North Carolina, 27705, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157, United States
Cleveland Clinic
Cleveland, Ohio, 44106, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
University of Wisconsin - Madison
Madison, Wisconsin, 53792, United States
Freedman BI, Locke JE, Reeves-Daniel AM, Julian BA. Apolipoprotein L1 Gene Effects on Kidney Transplantation. Semin Nephrol. 2017 Nov;37(6):530-537. doi: 10.1016/j.semnephrol.2017.07.006.
Julian BA, Gaston RS, Brown WM, Reeves-Daniel AM, Israni AK, Schladt DP, Pastan SO, Mohan S, Freedman BI, Divers J. Effect of Replacing Race With Apolipoprotein L1 Genotype in Calculation of Kidney Donor Risk Index. Am J Transplant. 2017 Jun;17(6):1540-1548. doi: 10.1111/ajt.14113. Epub 2017 Jan 3.
Dorr CR, Freedman BI, Hicks PJ, Brown WM, Russell GB, Julian BA, Pastan SO, Gautreaux MD, Muthusamy A, Chinnakotla S, Hauptfeld V, Bray RA, Kirk AD, Divers J, Israni AK. Deceased-Donor Apolipoprotein L1 Renal-Risk Variants Have Minimal Effects on Liver Transplant Outcomes. PLoS One. 2016 Apr 7;11(4):e0152775. doi: 10.1371/journal.pone.0152775. eCollection 2016.
Freedman BI, Pastan SO, Israni AK, Schladt D, Julian BA, Gautreaux MD, Hauptfeld V, Bray RA, Gebel HM, Kirk AD, Gaston RS, Rogers J, Farney AC, Orlando G, Stratta RJ, Mohan S, Ma L, Langefeld CD, Bowden DW, Hicks PJ, Palmer ND, Palanisamy A, Reeves-Daniel AM, Brown WM, Divers J. APOL1 Genotype and Kidney Transplantation Outcomes From Deceased African American Donors. Transplantation. 2016 Jan;100(1):194-202. doi: 10.1097/TP.0000000000000969.
Freedman BI, Julian BA. Should kidney donors be genotyped for APOL1 risk alleles? Kidney Int. 2015 Apr;87(4):671-3. doi: 10.1038/ki.2015.16. No abstract available.
Freedman BI, Julian BA, Pastan SO, Israni AK, Schladt D, Gautreaux MD, Hauptfeld V, Bray RA, Gebel HM, Kirk AD, Gaston RS, Rogers J, Farney AC, Orlando G, Stratta RJ, Mohan S, Ma L, Langefeld CD, Hicks PJ, Palmer ND, Adams PL, Palanisamy A, Reeves-Daniel AM, Divers J. Apolipoprotein L1 gene variants in deceased organ donors are associated with renal allograft failure. Am J Transplant. 2015 Jun;15(6):1615-22. doi: 10.1111/ajt.13223. Epub 2015 Mar 24.
Reeves-Daniel AM, DePalma JA, Bleyer AJ, Rocco MV, Murea M, Adams PL, Langefeld CD, Bowden DW, Hicks PJ, Stratta RJ, Lin JJ, Kiger DF, Gautreaux MD, Divers J, Freedman BI. The APOL1 gene and allograft survival after kidney transplantation. Am J Transplant. 2011 May;11(5):1025-30. doi: 10.1111/j.1600-6143.2011.03513.x. Epub 2011 Apr 12.
Lee BT, Kumar V, Williams TA, Abdi R, Bernhardy A, Dyer C, Conte S, Genovese G, Ross MD, Friedman DJ, Gaston R, Milford E, Pollak MR, Chandraker A. The APOL1 genotype of African American kidney transplant recipients does not impact 5-year allograft survival. Am J Transplant. 2012 Jul;12(7):1924-8. doi: 10.1111/j.1600-6143.2012.04033.x. Epub 2012 Apr 4.
Doshi MD, Ortigosa-Goggins M, Garg AX, Li L, Poggio ED, Winkler CA, Kopp JB. APOL1 Genotype and Renal Function of Black Living Donors. J Am Soc Nephrol. 2018 Apr;29(4):1309-1316. doi: 10.1681/ASN.2017060658. Epub 2018 Jan 16.
Aron AW, Dahl NK. Clinical Genetic Testing in Nephrology: Core Curriculum 2024. Am J Kidney Dis. 2024 Nov;84(5):632-645. doi: 10.1053/j.ajkd.2024.05.011. Epub 2024 Sep 26.
Study Completion
May 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 26, 2026
Record last verified: 2026-05
Study participants will have the option of receiving their APOL1 genotype test result from a Clinical Laboratory Improvement Amendments (CLIA) research lab. Deceased donor family decision makers will also have the option of receiving their loved one's APOL1 genotype test result from a CLIA research lab. Results will be made available after enrollment is complete.Those who wish to receive these results will have been informed of benefits and risks of requesting and receiving this information prior to consenting to participate in APOLLO and again at the time of requesting test results. Info graphics to aid in the decision process for requesting Individual Participant Data (IPD) are provided at the time of consent and on the APOLLO website. Prior to sending IPD, participants and deceased donor family decision makers will be asked to verify that they received and understand the information. They will be able to ask questions to local study staff or the Coordinating Center.
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Source: ClinicalTrials.gov.
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