ArticleTrials2025
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.
Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed.
- Comparison of primary analysis strategies of randomized controlled trials with multiple endpoints with application to kidney transplantation.Scientific reports · 2026Article
- Immune Monitoring Goes Viral - Torque Teno Virus for Immunologic Risk Stratification After Kidney Transplantation.Transplant international : official journal of the European Society for Organ Transplantation · 2025Review
Corrections and comments
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Authors and funding
7 authors.
Funding
Abstract
backgroundNon-interventional studies indicate an association between Torque Teno Virus (TTV) load in peripheral blood and immunosuppression related outcomes in kidney transplant recipients. This makes it a promising biomarker for guiding immunosuppression after kidney transplantation. The primary objective of the current trial is to demonstrate the safety, tolerability and preliminary efficacy of TTV-guided immunosuppression.
methodsFor this purpose, a randomised, controlled, interventional, two-arm, non-inferiority, patient- and assessor-blinded, international multicentre investigator-driven phase II trial was designed. A total of 260 stable, low-immunological-risk adult recipients of a kidney graft with Tacrolimus-based immunosuppression and TTV infection after month 3 post-transplant are recruited in 13 academic centres in six European countries. Subjects are randomised in a 1:1 ratio stratified by centre (allocation concealment) to receive Tacrolimus either guided by TTV load or according to the local centre standard for 9 months. The primary composite endpoint includes the occurrence of infections, biopsy-proven allograft rejection, graft loss or death. Secondary outcomes include month 12 protocol biopsies, development of de novo donor-specific antibodies, health-related quality of life and drug adherence. DISCUSSION: Detailed descriptions of the study design, planned statistical analysis and reporting of the results for the TTVguideIT trial are provided. This statistical analysis plan was submitted to the journal before the end of the trial and prior to data lock.
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