APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5,000
- 试验地点
- 36
- 主要终点
- Time to death-censored renal allograft failure from the UNOS database
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for Living Donors:
- •Living kidney donors with self-reported recent African ancestry (defined as African American, Afro-Caribbean, Hispanic black or African) will be eligible for inclusion.
排除标准
- •for Living Donors:
- •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,
- •Phase II started on 9/1/2023 and only Living Donors will be recruited for an additional 2 years.
结局指标
主要结局
Time to death-censored renal allograft failure from the UNOS database
时间窗: up to 4.5 years
Time from receipt of kidney transplant to death-censored renal allograft failure. Measured in days.
次要结局
- Time to sustained development of overt proteinuria in the outpatient setting.(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)
- 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)
- 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)
- Renal allograft failure in patients with End Stage Renal Disease defined based on Standardized Outcomes in Nephrology (SONG) criteria(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.(up to 4.5 years)