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

NCT05727709 | Unknown DMC

• 1 other identifier: CTTV study
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 5

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)

Conditions

Kidney Transplant Rejection; Kidney Transplant Infection; Virus; Immunosuppression

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Renal allograft biopsy and serum creatinine

  Any biopsy-proven acute rejection (Banff criterea) and clinical diagnosed acute rejection

  From day0 to day365 after kidney transplantation

Secondary Outcomes (3)

• Infection event

  From day0 to day365 after kidney transplantation

• donor-specific antibodies (DSA)

  From day0 to day365 after kidney transplantation

• donor derived cell-free DNA

  From day0 to day365 after kidney transplantation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study is designed as a national multi-center prospective observational double-blind cohort study. The main outcome measures are plasma Torque Teno Virus (TTV) load and the incidence of infection and acute rejection, which will be observed from day 1 before renal transplantation to 1 year after renal transplantation.The study population is renal transplant recipients. Double-blind refers to that both the medical staff in charge and the patients are blinded to the plasma TTV viral load at each follow-up visit, and this will be unblinded after the last follow-up visit of the last subject is completed.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tongji Hospital: lead
• Anapure BioScience: collaborator
• Caibo MedTech: collaborator
• SKM BioTech: collaborator

Study Sites (5)

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, 430030, China

RECRUITING

the First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

RECRUITING

Related Publications (10)

• 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.

  PMID: 24086067 BACKGROUND

• 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.

  PMID: 29243394 BACKGROUND

• 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.

  PMID: 34309698 BACKGROUND

• 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.

  PMID: 24267896 BACKGROUND

• 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.

  PMID: 30341363 BACKGROUND

• 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.

  PMID: 30981537 BACKGROUND

• 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.

  PMID: 31100359 BACKGROUND

• 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.

  PMID: 30468687 BACKGROUND

• 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.

  PMID: 29957546 BACKGROUND

• 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.

  PMID: 31883425 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

plasma

MeSH Terms

Conditions

Virus Diseases; Rejection, Psychology; Infections

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Gang Chen, PhD

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gang Chen, PhD

CONTACT

+8613006187015; gchen@tjh.tjmu.edu.cn

Lan Zhu, MD

CONTACT

zhulan@tjh.tjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Deputy director of Institute of OrganTransplantation

Study Record Dates

• First Submitted: February 5, 2023
• First Posted: February 14, 2023
• Study Start: March 15, 2023
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact tongjihlunli@163.com

Locations

CN (5)