An observational study in Kidney Diseases, Kidney Failure and Kidney Disease, Chronic, sponsored by Wake Forest University Health Sciences. Active, not recruiting at 18 sites in United States. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by Wake Forest University Health Sciences · Observational
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.
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 192 across 1,033 observational studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria for Living Donors:
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.
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.
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.
Time frame: up to 4.5 years
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.
Time frame: up to 4.5 years
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 \[in mg/dl\].
Time frame: up to 4.5 years
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
Time frame: 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)
Rate of change (i.e., slope of change) in estimated glomerular filtration rate based on serum creatinine concentration from UNOS and clinic data
Time frame: up to 4.5 years
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.
Time frame: up to 4.5 years
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.
Time frame: up to 4.5 years
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
Time frame: up to 4.5 years
Plan to share: 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.
Supporting information: Icf
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Wake Forest University Health Sciences