APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO)
- Conditions
- Kidney FailureKidney DiseasesKidney Disease, Chronic
- Registration Number
- NCT03615235
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief 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. 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to death-censored renal allograft failure from the UNOS database up to 4.5 years Time from receipt of kidney transplant to death-censored renal allograft failure. Measured in days.
- Secondary Outcome Measures
Name Time Method Time to sustained development of overt proteinuria in the outpatient setting. up to 4.5 years 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
The rate of loss of renal clearance function from clinical laboratory data up to 4.5 years Rate of change in the estimated glomerular filtration rate Measured in ml/min/1.73 m2.
The rate of change in serum creatinine concentration from clinical laboratory data up to 4.5 years Rate of change in the reciprocal of the serum creatinine concentration. Measured as 1/serum creatinine concentration \[in mg/dl\].
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 Rate of change (i.e., slope of change) in estimated glomerular filtration rate based on serum creatinine concentration from UNOS and clinic data
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) up to 4.5 years 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
Renal allograft failure in patients with End Stage Renal Disease defined based on Standardized Outcomes in Nephrology (SONG) criteria up to 4.5 years 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.
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. 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.
Trial Locations
- Locations (18)
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Joslin Diabetes Center / Harvard University
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
University of Miami / Miami Transplant Institute
🇺🇸Miami, Florida, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Ichan School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
University of Maryland School of Medicine
🇺🇸Baltimore, Maryland, United States
Saint Louis University Center for Transplantation
🇺🇸Saint Louis, Missouri, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Duke University
🇺🇸Durham, North Carolina, United States
Columbia University Irving Medical Center
🇺🇸New York, New York, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Michigan Medicine
🇺🇸Ann Arbor, Michigan, United States
Wake Forest School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
University of Wisconsin - Madison
🇺🇸Madison, Wisconsin, United States