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Kidney DiseasesAPOLLONCT03615235

APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO)

An observational study of Kidney Diseases and Kidney Failure, run by Wake Forest University Health Sciences at 18 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
How many people
5,000 participants
Where
18 sitesUnited States
Study dates
21 Mar 2019to 30 May 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: 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.

Who may be able to join

  • Living kidney donors with self-reported recent African ancestry (defined as African American, Afro-Caribbean, Hispanic black or African) will be eligible for inclusion.

Who cannot join

  • Participants who are unable or unwilling to provide informed consent.
  • Enrollment and bio sample collection from deceased donors at OPOs ended on May 31, 2023 and recruiting kidney transplant recipients ended on June 15, 2023.
  • Phase II started on 9/1/2023 and only Living Donors will be recruited for an additional 2 years.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • University of Michigan Medicine

    Ann Arbor, Michigan, 48109

  • Emory University School of Medicine

    Atlanta, Georgia, 30322

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201

  • Johns Hopkins University

    Baltimore, Maryland, 21205

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Joslin Diabetes Center / Harvard University

    Boston, Massachusetts, 02215

  • Cleveland Clinic

    Cleveland, Ohio, 44106

  • Duke University

    Durham, North Carolina, 27705

  • University of Wisconsin - Madison

    Madison, Wisconsin, 53792

  • University of Miami / Miami Transplant Institute

    Miami, Florida, 33133

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Ichan School of Medicine at Mount Sinai

    New York, New York, 10029

  • Columbia University Irving Medical Center

    New York, New York, 10032

  • Weill Cornell Medicine

    New York, New York, 10065

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University of California San Francisco

    San Francisco, California, 94143

  • Saint Louis University Center for Transplantation

    St Louis, Missouri, 63104

  • Wake Forest School of Medicine

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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.

Read the detailed description

The National Institutes of Health (NIH)-sponsored collaborative APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) is charged with prospectively assessing the effects of renal-risk variants (RRVs) in the apolipoprotein L1 gene (APOL1) on outcomes for kidneys from donors with recent African ancestry and the recipients of their kidneys, after deceased- and living-donor renal transplantation. For the purposes of APOLLO, recent African ancestry is defined as individuals with similar genetic make-up to those currently residing in Africa. APOLLO will also study the impact of APOL1 RRVs on the health of living kidney donors with recent African ancestry.

Keywords
Apolopoprotein L1 gene (APOL1), Kidney Transplantation, Kidney Donor, United Network for Organ Sharing (UNOS), Association of Organ Procurement Organizations (AOPO), Kidney Transplantation Outcomes Network
Medical subject headings
Kidney Diseases, Renal Insufficiency, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03615235
Study groupRoleWhat they receive
Recipients of a Kidney TransplantAPOLLO 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.
Living Kidney DonorsAPOLLO will prospectively assess post-donation renal outcomes in eligible living kidney donors at all transplant programs in the United States including Puerto Rico.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 4.5 years

Secondary outcomes (7)

  1. The rate of loss of renal clearance function from clinical laboratory data

    Rate of change in the estimated glomerular filtration rate Measured in ml/min/1.73 m2.

    Measured: up to 4.5 years

  2. The rate of change in serum creatinine concentration from clinical laboratory data

    Rate of change in the reciprocal of the serum creatinine concentration. Measured as 1/serum creatinine concentration [in mg/dl].

    Measured: up to 4.5 years

  3. Time to sustained development of overt proteinuria in the outpatient setting.

    Overt proteinuria is defined as urine protein:creatinine ratio (UPCR) >500 mg/g, urine albumin:creatinine ratio (UACR) >300 mg/g, or >2+ proteinuria on urine dipstick. This outcome requires repeat documentation of proteinuria using either UPCR, UACR or dipstick test >1 month after initial detection based on clinic data

    Measured: up to 4.5 years

  4. 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)

    Rate of change (i.e., slope of change) in estimated glomerular filtration rate based on serum creatinine concentration from UNOS and clinic data

    Measured: up to 4.5 years

  5. Renal allograft failure in patients with End Stage Renal Disease defined based on Standardized Outcomes in Nephrology (SONG) criteria

    Renal allograft failure in patients with End Stage Renal Disease defined based on Standardized Outcomes in Nephrology (SONG) criteria: return to chronic renal replacement therapy (dialysis for >90 days or submission of Centers for Medicare and Medicaid Services End Stage Renal Disease Medical Evidence Report [2728 Form]) or repeat kidney transplantation.36 This definition of renal allograft failure specifically excludes acute kidney injury (AKI), delayed graft function (DGF), or primary non-function (requirement of dialysis for the initial 90 days after kidney transplant or re-transplant within 90 days). The diagnoses of AKI, DGF and primary non-function will be abstracted from UNOS, clinic notes and hospital discharge summaries.

    Measured: up to 4.5 years

  6. The effects of donor APOL1 RRVs on time to "death or renal allograft failure" using UNOS data for all recipients of an APOLLO Deceased Donor Kidney Transplant.

    The effects of donor APOL1 RRVs on time to "death or renal allograft failure" using UNOS data for all recipients of an APOLLO Deceased Donor Kidney Transplant.

    Measured: up to 4.5 years

  7. he effects of donor APOL1 RRVs on time to "death-censored renal allograft failure (using UNOS data) or death from Corona Virus Disease of 2019 infection (COVID-19)

    The effects of donor APOL1 RRVs on time to "death-censored renal allograft failure (using UNOS data) or death from Corona Virus Disease of 2019 infection (COVID-19) (using APOLLO transplant program data)" among the subset of consented recipients of an APOLLO Deceased Donor Kidney Transplant

    Measured: up to 4.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2018
  2. Study start21 Mar 2019
  3. Primary completion30 May 2027 (estimated)
  4. Study completion30 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03615235
Sponsor's protocol ID
IRB00051561
Other IDs
U01DK116041, U01DK116040
Acronym
APOLLO
Status last verified
May 2026
First submitted
30 Jul 2018
Last updated
26 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 29703792

  • 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.

    PubMed 29523593

  • 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.

    PubMed 29110760

  • 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.

    PubMed 27862962

  • 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.

    PubMed 27054572

  • 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.

    PubMed 26566060

  • 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.

    PubMed 25826538

  • 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.

    PubMed 25809272

  • 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.

    PubMed 21486385

  • 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.

    PubMed 22487534

  • 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.

    PubMed 29339549

  • 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.

    PubMed 39340488

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Diseases and Kidney Failure, run by Wake Forest University Health Sciences at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to death-censored renal allograft failure from the UNOS database (time frame: up to 4.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03615235, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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