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.

Details

Title
Standard induction with basiliximab versus no induction in low immunological risk kidney transplant recipients: study protocol for a randomized controlled trial
Author
Ajlan, Aziza 1   VIAFID ORCID Logo  ; Aleid, Hassan 2 ; Ali, Tariq Zulfiquar 2 ; Joharji, Hala 1 ; Almeshari, Khalid 2 ; Nazmi, Ahmed Mohammed 2 ; Shah, Yaser 2 ; Devol, Edward 3 ; Alkortas, Dalal 1 ; Alabdulkarim, Zinah 1 ; Broering, Dieter 4 ; Alahmadi, Ibrahim 2 ; Ullah, Asad 2 ; Alotaibi, Anwar 3 ; Aljedai, Ahmed 5 

1  King Faisal Specialist Hospital and Research Centre (KFSHRC), Pharmaceutical Care Division MBC 11, Riyadh, Saudi Arabia (GRID:grid.415310.2) (ISNI:0000 0001 2191 4301) 
2  King Faisal Specialist Hospital and Research Centre (KFSHRC), Kidney & Pancreas Health Centre - Riyadh, KPT, Riyadh, Saudi Arabia (GRID:grid.415310.2) (ISNI:0000 0001 2191 4301) 
3  Biostats, Epidemiology and Scientific Computing Department, Riyadh, Saudi Arabia (GRID:grid.415310.2) 
4  Organ Transplant Centre of Excellence- Riyadh, OTC, Riyadh, Saudi Arabia (GRID:grid.415310.2) 
5  King Faisal Specialist Hospital and Research Centre (KFSHRC), Pharmaceutical Care Division MBC 11, Riyadh, Saudi Arabia (GRID:grid.415310.2) (ISNI:0000 0001 2191 4301); Deputyship of Therapeutic Affairs, Ministry of Health, Riyadh, Saudi Arabia (GRID:grid.415696.9) 
Pages
414
Publication year
2021
Publication date
Dec 2021
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-021-05253-1
ProQuest document ID
2730341948
Copyright
© The Author(s) 2021. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.