APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) (APOLLO)
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|ClinicalTrials.gov Identifier: NCT03615235|
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : April 11, 2022
|Condition or disease|
|Kidney Diseases Kidney Failure Kidney Disease, Chronic|
|Study Type :||Observational|
|Estimated Enrollment :||5000 participants|
|Official Title:||APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO)|
|Actual Study Start Date :||May 16, 2019|
|Estimated Primary Completion Date :||May 2023|
|Estimated Study Completion Date :||September 2023|
Recipients of a Kidney Transplant
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.
Living Kidney Donors
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 Frame: up to 4.5 years ]Time from receipt of kidney transplant to death-censored renal allograft failure. Measured in days.
- The rate of loss of renal clearance function from clinical laboratory data [ Time Frame: 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 [ Time Frame: 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].
- Time to sustained development of overt proteinuria in the outpatient setting. [ Time Frame: 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
- 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) [ Time Frame: 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
- Renal allograft failure in patients with ESRD defined based on Standardized Outcomes in Nephrology (SONG) criteria [ Time Frame: up to 4.5 years ]Renal allograft failure in patients with ESRD 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 [CMS] ESRD 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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03615235
|Contact: Laurie P. Russell, MSemail@example.com|
|Contact: Benjamin Bagwell, BSfirstname.lastname@example.org|
|Principal Investigator:||Barry I. Freedman, MD||Wake Forest University Health Sciences|
|Principal Investigator:||David M. Reboussin, PhD||Wake Forest University Health Sciences|
|Study Director:||Paul L. Kimmel, MD||Natl Institute of Diabetes, Digestive & Kidney Diseases|
|Study Chair:||Marva Moxey-Mims, MD||Children's Natl Health System; George Washington Univ Sch of Med and Health Serv|