标准诱导联合巴利昔单抗与低免疫风险肾移植受者中不进行诱导治疗的比较：一项随机对照试验的研究方案。
Standard induction with basiliximab versus no induction in low immunological risk kidney transplant recipients: study protocol for a randomized controlled trial.
机构信息
King Faisal Specialist Hospital and Research Centre (KFSHRC), Pharmaceutical Care Division MBC 11, Riyadh, Saudi Arabia.
King Faisal Specialist Hospital and Research Centre (KFSHRC), Kidney & Pancreas Health Centre - Riyadh, KPT, Riyadh, Saudi Arabia.
出版信息
Trials. 2021 Jun 24;22(1):414. doi: 10.1186/s13063-021-05253-1.
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 been 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.
METHODS
Prospective, randomized, double blind, non-inferiority, controlled clinical trial EXPECTED OUTCOMES: 1. Primary outcomes: Biopsy-proven acute rejection within first year following transplant 2.
SECONDARY OUTCOMES
a. Patient and graft survival at 1 year b. eGFR at 6 months and at 12 months c. Emergence of de novo donor-specific antibodies (DSAs) TRIAL REGISTRATION: The study has been prospectively registered at clinicaltrials.gov (NTC: 04404127). Registered on 27 May 2020.
背景
低免疫风险肾移植受者推荐使用白介素-2 受体拮抗剂（IL2-RA）诱导治疗作为一线药物。然而，在他克莫司免疫抑制背景下，IL2-RA 的作用尚未得到充分研究。
目的
根据 KFSHRC 方案，比较低免疫风险肾移植受者中使用 2 剂巴利昔单抗与不使用诱导治疗的两种不同诱导治疗策略。
方法
前瞻性、随机、双盲、非劣效、对照临床试验。
预期结果
- 主要结局：移植后 1 年内活检证实的急性排斥反应。2. 次要结局：a. 1 年时的患者和移植物存活率。b. 6 个月和 12 个月时的 eGFR。c. 新出现的供体特异性抗体（DSAs）。
试验注册
该研究已在 clinicaltrials.gov 上进行了前瞻性注册（NTC：04404127）。注册于 2020 年 5 月 27 日。
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