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

Recruiting

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

• Registration Number: NCT05727709
• Lead Sponsor: Tongji Hospital

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-05
• Study First Submitted QC: 2023-02-05
• Study First Posted: 2023-02-14
• Study Start: 2023-03-15
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-08-22
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Renal allograft biopsy and serum creatinine	From day0 to day365 after kidney transplantation	Any biopsy-proven acute rejection (Banff criterea) and clinical diagnosed acute rejection

Secondary Outcome Measures

Name	Time	Method
donor-specific antibodies (DSA)	From day0 to day365 after kidney transplantation	the development of de novo DSA or a 30% increase of MFI value in preformed DSA
donor derived cell-free DNA	From day0 to day365 after kidney transplantation	An increase in absolute or percent donor derived-cell free DNA from 1 month post-transplant
Infection event	From day0 to day365 after kidney transplantation	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

Trial Locations

Locations (5)

The First Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, China

Changhai Hospital affiliated to Naval Military Medical University; 🇨🇳 Shanghai, China

the First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, China

West China Hospital，Sichuan University; 🇨🇳 Chengdu, China

Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology; 🇨🇳 Wuhan, China