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10.1186/s13063-025-09119-8 http://scihub22266oqcxt.onion/10.1186/s13063-025-09119-8 C12548177!12548177 !41131560     free     free     free Deprecated: Implicit conversion from float 217.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 217.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 217.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 217.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 217.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 251.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 251.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 251.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 251.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 251.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 251.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 251.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 251.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 251.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 284.79999999999995 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 284.79999999999995 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 284.79999999999995 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 284.79999999999995 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 284.79999999999995 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 318.4 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 318.4 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 318.4 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 318.4 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 318.4 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 318.4 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 318.4 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Warning: imagejpeg(C:\Inetpub\vhosts\kidney.de\httpdocs\phplern\41131560 .jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117       Trials 2025 ; 26 (1 ): 432 Nephropedia Template TP {{tp|p=41131560 |t=2025. 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 |pdf=|usr=}}{{41131560 }} gab.com Text 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 JO: Trials http://www.kidney.de/pget.php?&tw=1&pmid=41131560 #FOAvip BACKGROUND: Non-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. METHODS: For 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. Twit Text FOAVip 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 ????Trials http://www.kidney.de/pget.php?&tw=1&pmid=41131560 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=41131560 #FOAvip English Wikipedia <ref>{{Cite pmid|41131560 }}</ref> 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 #MMPMID41131560 Herkner F ; Haupenthal F ; Kapps S ; Doberer K ; Herkner H ; König F ; Bond G Trials 2025[Oct]; 26 (1 ): 432 PMID41131560 show ga BACKGROUND: Non-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. METHODS: For 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. |*DNA Virus Infections/virology/immunology/diagnosis [MESH] |*Graft Rejection/prevention & control/immunology/virology [MESH] |*Immunosuppressive Agents/adverse effects/administration & dosage [MESH] |*Kidney Transplantation/adverse effects/mortality [MESH] |*Tacrolimus/adverse effects/administration & dosage [MESH] |*Torque teno virus/immunology/pathogenicity [MESH] |Data Interpretation, Statistical [MESH] |Equivalence Trials as Topic [MESH] |Europe [MESH] |Graft Survival/drug effects [MESH] |Humans [MESH] |Multicenter Studies as Topic [MESH] |Randomized Controlled Trials as Topic [MESH] |Time Factors [MESH] |Treatment Outcome [MESH]Statistical analysis plan for TTVguideIT-a multicentre, patient- and (epmc).pdf DeepDyve Pubget Overpricing