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

Tongji Hospital

Status: Enrolling

Conditions: Virus; Kidney Transplant Infection; Immunosuppression; Kidney Transplant Rejection

Study type: Observational

Funder types: Other

Identifiers

NCT05727709

CTTV study

Details and patient eligibility

About

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)

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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