Standard Induction With Basiliximab Versus No-Induction in Low Immunological Risk Kidney Transplant Recipients - Prospective Randomized Double Blind Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Rate of biopsy proven acute rejection within first year following transplant
研究概览
简要总结
Background:
Induction therapy with IL-2 receptor antagonist (IL2-RA) is recommended as a first line agent in low immunological risk kidney transplant recipients. However, the role of IL2-RA in the setting of tacrolimus-based immunosuppression has not fully investigated
Aims:
To compare different induction therapeutic strategies with 2 doses of Basiliximab vs. no induction) in low immunologic risk kidney transplant recipients as per KFSHRC protocol (Appendix 2)
Methods:
Prospective, randomized, double blind, non-inferiority, controlled clinical trial
Expected Outcomes:
- Primary outcomes:
Biopsy proven acute rejection within first year following transplant 2. Secondary outcomes:
- Patient and graft survival at 1 year
- Estimated glomerular filtration rate (eGFR) at 6 months and at 12 months
- Emergence of de novo donor specific antibodies (DSAs)
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
- Double (Participant, Investigator)
盲法说明
The trial will be blinded with respect to Basiliximab induction allocation. The study will be blinded to subjects and site study investigators, with the following exceptions:
A single pharmacist A single biostatistician Patients with receive either basiliximab or an intravenous piggyback (IVPB) with normal saline depending on their allocation.
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 ≥ 18 years
- •Living donor
- •Low immunological risk (defined as):
- •First (primary) transplant
- •≤ 4 antigen mismatches (HLA matching scheme)
- •Negative HLA Ab screening
排除标准
- •• High immunological risk
- •HLA identical or zero mismatched transplants
- •Receiving cyclosporin as primary maintenance immunosuppressant
- •Human immunodeficiency virus (HIV) co-infection
- •Pregnant or nursing female
- •Has received an investigational medication within the past 30 days
- •Has a known contraindication to the administration of Basiliximab
- •Suspected or known to have a serious infection
- •Multi-organ transplant
研究组 & 干预措施
No induction Arm
干预措施: Normal Saline (Other)
Induction with basiliximab
干预措施: Basiliximab 20 milligram [Simulect] (Drug)
结局指标
主要结局
Rate of biopsy proven acute rejection within first year following transplant
时间窗: 1 year after transplant
次要结局
- Rate of graft survival at 1 year(1 year after transplant)
- Rate of emergence of de novo donor specific antibodies (DSAs)(1 year after transplant)
- Rate of decline in eGFR at 6 months and at 12 months(1 year after transplant)
研究者
Aziza Ajlan
Aziza A. Ajlan, B.Sc. Pharm. BCPS. Clinical pharmacy specialist- Solid Organ Transplant
King Faisal Specialist Hospital & Research Center