A noninferiority design for a delayed calcineurin inhibitor substitution trial in kidney transplantation.

ABSTRACT: Improving long-term kidney transplant outcomes requires novel treatment strategies, including delayed calcineurin inhibitor (CNI) substitution, tested using informative trial designs. An alternative approach to the usual superiority-based trial is a noninferiority trial design that tests whether an investigational agent is not unacceptably worse than standard of care. An informative noninferiority design, with biopsy-proven acute rejection (BPAR) as the endpoint, requires determination of a prespecified, evidence-based noninferiority margin for BPAR. No such information is available for delayed CNI substitution in kidney transplantation. Herein we analyzed data from recent kidney transplant trials of CNI withdrawal and "real world" CNI- based standard of care, containing subjects with well

SUBMITTER: Nickerson PW 

PROVIDER: S-EPMC8048676 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature