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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05727709

Acronym

TTV

Enrollment

220

Registered

2023-02-14

Start date

2023-03-15

Completion date

2024-06-30

Last updated

2023-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunosuppression, Kidney Transplant Infection, Kidney Transplant Rejection, Virus

Keywords

kidney transplantation, rejection, infection, donor specific antibodies, cell-free DNA, Torque Teno Virus, immuno-monitoring

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)

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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

Countries

China

Contacts

Primary ContactGang Chen, PhD

gchen@tjh.tjmu.edu.cn+8613006187015

Backup ContactLan Zhu, MD

zhulan@tjh.tjmu.edu.cn

Outcome results