The goal of this observational study is to learn about dynamic changes of Torquetenovirus (TTV) load in Chinese renal transplant recipients. The main questions it aims to answer are:

• Is there correlation between TTV load and rejection?
• Is there correlation between TTV load and infection?
• Can changes in the TTV load of kidney transplant recipients predict rejection or infection?

Participants will:

• receive 13 follow-up visits within 1 year after kidney transplantation
• provide 2 ml of whole blood for TTV load testing and other related testing at each follow-up
• provide 10 ml of whole blood for dd-cfDNA testing at four follow-ups (1, 3, 6 and 12 months after transplantation)
• provide 1 ml of serum for donor-specific antibody testing at three follow-ups (1, 6 and 12 months after transplantation)

Inclusion Criteria:

• Receiving ABO compatible renal allotransplantation from the initiation of the study to December 31, 2023
• Receiving tacrolimus /mycophenolate mofetil(or mycophenolic acid)/prednisone as maintenance immunosuppression after renal transplantation
• Receiving universal prophylaxis for CMV infection and PJP infection

Exclusion Criteria:

• Receiving combined liver-kidney, pancreas-kidney or heart-kidney transplantation
• Recipients with active hepatitis B or hepatitis C infection
• Recipients with anticipated irregular follow-up

The study is designed as a national multi-center prospective observational double-blind cohort study. The main outcome measures are plasma Torque Teno Virus (TTV) load and the incidence of infection and acute rejection, which will be observed from day 1 before renal transplantation to 1 year after renal transplantation.The study population is renal transplant recipients. Double-blind refers to that both the medical staff in charge and the patients are blinded to the plasma TTV viral load at each follow-up visit, and this will be unblinded after the last follow-up visit of the last subject is completed.

all IPD that underlie results in a publication

Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis

Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact tongjihlunli@163.com