Monitoring Torquetenovirus levels in kidney transplant patients in China
Dynamic Changes of Torquetenovirus Load in Chinese Renal Transplant Recipients During Immunosuppressive Therapy: A Double-blind Multicenter Prospective Observational Cohort Study
This study is testing if tracking the levels of a virus called Torquetenovirus in kidney transplant patients can help predict if they will have problems with their transplant, like rejection or infection.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 220 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Drugs / interventions | prednisone |
| Locations | 5 sites (Chengdu and 4 other locations) |
| Trial ID | NCT05727709 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the dynamic changes of Torquetenovirus (TTV) load in Chinese renal transplant recipients. It seeks to determine the correlation between TTV load and kidney transplant rejection or infection, and whether changes in TTV load can predict these complications. Participants will undergo 13 follow-up visits within one year post-transplant, providing blood samples for TTV load testing, donor-specific antibody testing, and cell-free DNA analysis. The study will help enhance understanding of viral load dynamics in relation to transplant outcomes.
Who should consider this trial
Good fit: Ideal candidates are Chinese adults receiving ABO compatible renal allotransplantation with specific immunosuppressive therapy.
Not a fit: Patients who have received combined organ transplants or have active hepatitis infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of kidney transplant recipients, potentially reducing the risk of rejection and infection.
How similar studies have performed: While the specific approach of monitoring TTV load in this context may be novel, similar studies have shown the importance of viral load in predicting transplant outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chengdu and 4 other locations
- West China Hospital，Sichuan University — Chengdu, China (Recruiting)
- The First Affiliated Hospital of Zhejiang University — Hangzhou, China (Recruiting)
- Changhai Hospital affiliated to Naval Military Medical University — Shanghai, China (Recruiting)
- Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology — Wuhan, China (Recruiting)
- the First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, China (Recruiting)
Study contacts
- Principal investigator: Gang Chen, PhD — Tongji Hospital
- Study coordinator: Gang Chen, PhD
- Email: gchen@tjh.tjmu.edu.cn
- Phone: +8613006187015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.