Long-term Outcomes After Conversion to a Belatacept-based Immunosuppression in Kidney Transplant
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 324
- 主要终点
- Patient survival after conversion to belatacept
研究概览
简要总结
belatacept is a selective T-cell co-stimulation blocker that was approved by Food and Drug Administration (FDA) in 2011 for the prophylaxis of graft rejection in adult kidney transplant recipients. This treatment is indicated as an alternative to Calcineurin Inhibitors (CNIs) for prophylaxis of graft rejection in de novo renal transplant recipients. Long term efficacy and safety outcomes of a kidney transplant population converted to a belatacept regimen after transplant have not been yet reported.
详细描述
belatacept is a selective T-cell co-stimulation blocker that was approved by Food and Drug Administration (FDA) in 2011 for the prophylaxis of graft rejection in adult kidney transplant recipients. This treatment is indicated as an alternative to Calcineurin Inhibitors (CNIs) for prophylaxis of graft rejection in de novo renal transplant recipients. Major studies evaluating belatacept showed that de novo kidney transplant patients treated with belatacept presented an improved renal function with a higher average estimated glomerular filtration rate (eGFR) compared to ciclosporin (CsA) regimen in patients. Conversion to belatacept after transplant seems to be safe even in highly sensitized patients. However, long term efficacy and safety outcomes of a kidney transplant population converted to a belatacept regimen after transplant and compared to a matched control group under a CNIs regimen have not been yet reported.
A multicenter cohort of kidney transplant patients, will be use to match patients converted to a belatacept immunosuppressive regimen to a control group under CNIs immunosuppressive regimen.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female, over 18 years of age
- •Recipient of kidney allograft from a living donor or a deceased donor
排除标准
- •Graft loss during the first three months post-transplant
- •Epstein-Barr virus Seronegative in the belatacept group
研究组 & 干预措施
converted to a belatacept based immunosuppression
Belatacept: infusion on Days 1, 15, 29, 43, 57 then every 28 days. All patients received a background maintenance immunosuppressive regimen of mycophenolate mofetil or mycophenolic acid, with adjunctive corticosteroids, according to their immunosuppressive regimen at the time of enrollment.
干预措施: Conversion to a belatacept regimen (Drug)
结局指标
主要结局
Patient survival after conversion to belatacept
时间窗: 5 years
Patient survival after conversion to a belatacept regimen
Allograft survival after conversion to belatacept
时间窗: 5 years
Graft loss is defined as either functional loss or physical loss (nephrectomy). Functional loss is defined as an eGFR\< 15 ml/min/1.73m2 or consecutive days of dialysis. For patients who died with a functioning graft, graft survival will be censored at the time of death as a survived or functional graft.
次要结局
未报告次要终点