Table 1 Trial registry data
Primary registry and trial identifying number | EU CT-Number 2022-500024-30-00 |
Date of registration in primary registry | 07.03.2022 |
Source of monetary or material support | Research and Innovation Action within the Horizon 2020 framework; project name: TTVguideTX; grant agreement number: 896932; project coordinator: Dr Gregor Bond. |
Sponsor | Medical University of Vienna, Spitalgasse 23, 1090 Vienna, Austria |
Contact for public and scientific queries | Assoc. Prof. PD. Dr Gregor Bond, PhD Nephrology and Dialysis, General Hospital Vienna Währinger Gürtel 18-20, 1090 Vienna, Austria email: gregor.bond@meduniwien.ac.at phone/fax: +43 (0)1 40400-43910/-43920 |
Public title | Personalised dosing of immunosuppression after kidney transplantation by measuring immune system functionality |
Scientific title | A non-inferiority, randomised and controlled trial to compare the safety, tolerability and preliminary efficacy of standard and Torque Teno virus-guided immunosuppression in stable adult kidney transplant recipients with low immunological risk in the first year after transplantation |
Countries of recruitment | Austria, the Czech Republic, France, Germany, the Netherlands, and Spain; 13 academic centres. |
Short title | TTV GUIDE IT |
Health condition studied | Kidney transplantation |
Intervention | Active group: tacrolimus target set according to plasma Torque Teno virus load (target 4.6 to 6.2 log10 copies/mL) quantified by real-time PCR (TTV R-GENE) every 6 weeks Control: tacrolimus target set according to the local centre standard |
Trial schedule | Screening: week 1 to month 3 post-transplantation; Randomisation: month 4 post-transplantation; Intervention: 9 months (last follow-up: last 6 weeks) |
Key inclusion and exclusion criteria | Key inclusion criteria: recipient of a kidney allograft, adult (≥18 years of age), tacrolimus-based immunosuppression, TTV infection Key exclusion criteria: high immunological risk, no standard tacrolimus target immunosuppression according to the local centre definition |
Trial type | Randomised, controlled, interventional, two-arm, non-inferiority, patient- and assessor-blinded, multinational, investigator-driven, phase II |
Date of first enrolment | 25th of August 2022 |
Planned end (last patient last visit) | April 2025 |
Target sample size | 260 |
Randomisation and concealment | 1:1 randomisation; allocation concealment |
Primary endpoint | A composite of one of the following: 1. Infectious disease event (diagnosis based on the Infectious Diseases Guidelines 2019 published by the American Society of Transplantation) requiring one of the following: - Application of anti-bacterial, -fungal, -viral and -protozoal drugs. - Reduction of immunosuppression. - Inpatient treatment SARS-CoV-2 infection with or without COVID-19 is excluded. 2. Allograft rejection detected upon indication biopsy, based on the Banff 2019 Kidney Meeting Report, including borderline rejection suspicious for T-cell-mediated rejection (BL TCMR). 3. Graft loss 4. Death |
Key secondary outcomes | • Episodes of infection and graft rejection defined by the treating medical personnel • Estimated glomerular filtration rate (eGFR; current CKD-EPI and MDRD abbreviated) • Rejection detected by protocol biopsy at month 12 post-transplantation according to the Banff 2019 meeting report and molecular microscopy • de novo donor-specific antibodies • Health-related quality of life: SF-36 and MTSOSD-59R questionnaires • Drug adherence assessed according to paper-based assessment, MEMS® Buttons (AARDEX Group, Switzerland), BAASIS questionnaire, claimed prescriptions, psychological evaluation and tacrolimus trough level variability |