PHASE 4, STUDY OF THE EFFECT OF EARLY STEROID WITHDRAWAL IN RENAL TRANSPLANT RECEPIENTS OF A LIVING-RELATED DONOR
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- ACUTE REJECTION FREQUENCY AND SEVERITY
研究概览
简要总结
BACKGROUND: Non-steroid maintenance immunosuppression after transplantation can improve long-term lipid and hemodynamic profiles without severe acute rejection (AR) events that alter graft function or survival. Our objective was to evaluate the effects of early steroid withdrawal (ESW) on the frequency and severity of AR using an immunosuppressive scheme consisting of mycophenolate (MMF) and tacrolimus (TAC) in combination with an induction treatment with basiliximab.
METHODS: A randomized clinical trial was performed on first renal transplant recipients. In the ESW group, patients were selected for corticosteroid treatment withdrawal on the fifth day post-transplantation. In the Control group, patients continued steroid treatment.
详细描述
INTRODUCTION New immunosuppressant drugs have lowered early acute rejection (AR) rates with controversial results on improved long-term renal graft and patient survival (1-3).
An ideal maintenance immunosuppressant treatment for an improved long-term renal graft function and survival has not been determined (4). With new and more potent immunosuppressants available, new strategies are being developed to reduce or eliminate the use of steroids after transplantation due to important side effects and the lack of benefit in long-term graft and patient survival (5-8).
Immunosuppression minimization strategies have led to the possibility of early steroid withdrawal with similar results for AR incidence, function, and renal graft as well as patient survival among those that continue steroid treatment after transplantation (9-21).
Current clinical practice guidelines for kidney disease improving global outcomes (KDIGO) suggest that steroids could be withdrawn from patients with low immunological risk after kidney transplantation when receiving induction immunosuppressive therapy (22). However, a recent meta-analysis indicated that steroid removal or withdrawal after renal transplantation could be linked to the risk of kidney graft AR on all immunosuppression regimens (5). Nevertheless, kidney graft rejection with non-steroidal immunosuppression shows mild rejection characteristics with no negative impact on function or graft and patient survival, but this type of intervention is still controversial (5).
In Mexico, there is no information concerning therapeutic intervention of steroid withdrawal after transplantation, and it is not common practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years of age
- •Panel reactive antibody (PRA) class I and II HLA <20%.
- •Any gender
- •Living donor
排除标准
- •Patients with co-morbidities that required the use of steroid,
- •Delayed graft function or AR during the 5 days post-transplantation,
- •Along with patients that decided to leave the study.
- •Multiorganic recipients
研究组 & 干预措施
ESW group
CORTICOSTEDORID TREATMENT WAS AS FOLLOWS: day zero post-transplantation (DP 0), 500 mg/day of MPD; (DP 1), 250 mg MPD; (DP 2), 125 mg MPD; (DP 3), 60 mg MPD; (DP 4), 30 mg MPD; and (DP 5), PREDNISONE AS DOSES 1 MG/KG (1 MONTH) AND A REDUCTION TO ACHIEVE 0.1 MG/KG IN THE 3rd MONTH.
干预措施: ESW group (Drug)
结局指标
主要结局
ACUTE REJECTION FREQUENCY AND SEVERITY
时间窗: UP TO 1 YEAR OF FOLLOW UP
ACUTE REJECTION ACCORDING TO BANFF´S CLASSIFICATION, LIMITROPHIC CHANGES (1), ACUTE REJECTION 1A (2), 1B (3), 2A (4), 2B (5); CHRONIC REJECTION (6)
次要结局
- RENAL GRAFT FUNCTION(UP TO 1 YEAR OF FOLLOW UP)