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Statistical analysis plan for TTVguideIT—a multicentre, patient- and assessor-blinded, non-inferiority, randomised and controlled phase II trial to compare standard and Torque Teno virus-guided immunosuppression in kidney transplant recipients in the first year after transplantation

Crossref DOI link: https://doi.org/10.1186/s13063-025-09119-8

Published Online: 2025-10-23

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

Herkner, Felix

Haupenthal, Frederik

Kapps, Sebastian

Doberer, Konstantin

Herkner, Harald

König, Franz

Bond, Gregor https://orcid.org/0000-0003-0440-3053
Funding

Funding for this research was provided by:

Horizon 2020 Framework Programme (896932)
License Information

Text and Data Mining valid from 2025-10-23

Version of Record valid from 2025-10-23
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Article History

Received: 12 May 2025

Accepted: 25 August 2025

First Online: 23 October 2025

Declarations

:

: The trial was approved on 04 July 2022 according to Regulation (EU) 536/2014 via the clinical trials information system (CTIS) for all participating countries. Written informed consent to participate has been obtained from all participants.

: Not applicable—no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. The participant information materials and informed consent form are available from the corresponding author on request.

: The authors declare that they have no competing interests.

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