Dynamic Changes of Torquetenovirus (TTV) Load in Chinese Renal Transplant Recipients
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Outcome Measures
Primary Outcome Measures
- Acute rejection event [From day0 to day365 after kidney transplantation]
Any biopsy-proven acute rejection and clinical diagnosed acute rejection
Secondary Outcome Measures
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of Zhejiang University | Hangzhou | China | ||
| 2 | Changhai Hospital affiliated to Naval Military Medical University | Shanghai | China | ||
| 3 | Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology | Wuhan | China | 430030 | |
| 4 | the First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | China |
Sponsors and Collaborators
- Tongji Hospital
- Anapure BioScience
- Caibo MedTech
- SKM BioTech
Investigators
- Principal Investigator: Gang Chen, PhD, Tongji Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Ahlenstiel-Grunow T, Pape L. Novel ways to monitor immunosuppression in pediatric kidney transplant recipients-underlying concepts and emerging data. Mol Cell Pediatr. 2021 Jul 26;8(1):8. doi: 10.1186/s40348-021-00118-8. Erratum In: Mol Cell Pediatr. 2021 Sep 30;8(1):14.
- De Vlaminck I, Khush KK, Strehl C, Kohli B, Luikart H, Neff NF, Okamoto J, Snyder TM, Cornfield DN, Nicolls MR, Weill D, Bernstein D, Valantine HA, Quake SR. Temporal response of the human virome to immunosuppression and antiviral therapy. Cell. 2013 Nov 21;155(5):1178-87. doi: 10.1016/j.cell.2013.10.034.
- Fernandez-Ruiz M, Albert E, Gimenez E, Rodriguez-Goncer I, Andres A, Navarro D, Aguado JM. Early kinetics of Torque Teno virus DNA load and BK polyomavirus viremia after kidney transplantation. Transpl Infect Dis. 2020 Apr;22(2):e13240. doi: 10.1111/tid.13240. Epub 2020 Jan 9. No abstract available.
- Fishman JA. Opportunistic infections--coming to the limits of immunosuppression? Cold Spring Harb Perspect Med. 2013 Oct 1;3(10):a015669. doi: 10.1101/cshperspect.a015669.
- Focosi D, Maggi F. Torque teno virus monitoring in transplantation: The quest for standardization. Am J Transplant. 2019 May;19(5):1599-1601. doi: 10.1111/ajt.15194. Epub 2018 Dec 17. No abstract available.
- Haas M, Loupy A, Lefaucheur C, Roufosse C, Glotz D, Seron D, Nankivell BJ, Halloran PF, Colvin RB, Akalin E, Alachkar N, Bagnasco S, Bouatou Y, Becker JU, Cornell LD, Duong van Huyen JP, Gibson IW, Kraus ES, Mannon RB, Naesens M, Nickeleit V, Nickerson P, Segev DL, Singh HK, Stegall M, Randhawa P, Racusen L, Solez K, Mengel M. The Banff 2017 Kidney Meeting Report: Revised diagnostic criteria for chronic active T cell-mediated rejection, antibody-mediated rejection, and prospects for integrative endpoints for next-generation clinical trials. Am J Transplant. 2018 Feb;18(2):293-307. doi: 10.1111/ajt.14625. Epub 2018 Jan 21.
- Kulifaj D, Durgueil-Lariviere B, Meynier F, Munteanu E, Pichon N, Dube M, Joannes M, Essig M, Hantz S, Barranger C, Alain S. Development of a standardized real time PCR for Torque teno viruses (TTV) viral load detection and quantification: A new tool for immune monitoring. J Clin Virol. 2018 Aug;105:118-127. doi: 10.1016/j.jcv.2018.06.010. Epub 2018 Jun 11.
- Maggi F, Focosi D, Statzu M, Bianco G, Costa C, Macera L, Spezia PG, Medici C, Albert E, Navarro D, Scagnolari C, Pistello M, Cavallo R, Antonelli G. Early Post-Transplant Torquetenovirus Viremia Predicts Cytomegalovirus Reactivations In Solid Organ Transplant Recipients. Sci Rep. 2018 Oct 19;8(1):15490. doi: 10.1038/s41598-018-33909-7.
- Rezahosseini O, Drabe CH, Sorensen SS, Rasmussen A, Perch M, Ostrowski SR, Nielsen SD. Torque-Teno virus viral load as a potential endogenous marker of immune function in solid organ transplantation. Transplant Rev (Orlando). 2019 Jul;33(3):137-144. doi: 10.1016/j.trre.2019.03.004. Epub 2019 Apr 4.
- Solis M, Velay A, Gantner P, Bausson J, Filipputtu A, Freitag R, Moulin B, Caillard S, Fafi-Kremer S. Torquetenovirus viremia for early prediction of graft rejection after kidney transplantation. J Infect. 2019 Jul;79(1):56-60. doi: 10.1016/j.jinf.2019.05.010. Epub 2019 May 14.
- CTTV study