Dynamic Changes of Torquetenovirus (TTV) Load in Chinese Renal Transplant Recipients

Study Overview
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Brief Summary
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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)

Official Title
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Dynamic Changes of Torquetenovirus Load in Chinese Renal Transplant Recipients During Immunosuppressive Therapy: A Double-blind Multicenter Prospective Observational Cohort Study

Conditions
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Kidney Transplant Rejection, Kidney Transplant Infection, Virus, Immunosuppression

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal allograft biopsy and serum creatinine | Any biopsy-proven acute rejection (Banff criterea) and clinical diagnosed acute rejection | From day0 to day365 after kidney transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection event | Any bacterial, fungal (including PJP), mycobacterial, or viral (including CMV viremia, EB viremia, BK Viremia, BK Viruria, etc.) infection requiring hospitalization or prolongation of hospitalization, or requiring intravenous antibiotics or therapeutic use of antiviral drugs, or requiring reduction of immunosuppressive drugs | From day0 to day365 after kidney transplantation | 
| donor-specific antibodies (DSA) | the development of de novo DSA or a 30% increase of MFI value in preformed DSA | From day0 to day365 after kidney transplantation | 
| donor derived cell-free DNA | An increase in absolute or percent donor derived-cell free DNA from 1 month post-transplant | From day0 to day365 after kidney transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kidney transplantation, rejection, infection, donor specific antibodies, cell-free DNA, Torque Teno Virus, immuno-monitoring