Standard induction with basiliximab versus no induction in low immunological risk kidney transplant recipients: study protocol for a randomized controlled trial

• 出版年: Trials
• 主要な著者: Aziza Ajlan, Hassan Aleid, Tariq Zulfiquar Ali, Hala Joharji, Khalid Almeshari, Ahmed Mohammed Nazmi, Yaser Shah, Edward Devol, Dalal Alkortas, Zinah Alabdulkarim, Dieter Broering, Ibrahim Alahmadi, Asad Ullah, Anwar Alotaibi, Ahmed Aljedai
• フォーマット: 論文
• 言語: 英語
• 出版事項: BMC 2021-06-01
• オンライン･アクセス: https://doi.org/10.1186/s13063-021-05253-1

Abstract 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.