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Kidney Transplant RejectionTTVNCT05727709

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

An observational study of Kidney Transplant Rejection and Kidney Transplant Infection, run by Tongji Hospital at 5 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
How many people
220 participants
Where
5 sitesChina
Study dates
15 Mar 2023to 30 Jun 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

Gang Chen, PhD contact

+8613006187015

gchen@tjh.tjmu.edu.cn

Lan Zhu, MD contact

zhulan@tjh.tjmu.edu.cn

5 sites in 1 country

China5 sites, 5 recruiting

  • West China Hospital，Sichuan University

    Chengdu

    Tao Lin, PhD, 18980602093, dr_taolin@163.com

    Tao Lin, Dr.

    Recruiting

  • The First Affiliated Hospital of Zhejiang University

    Hangzhou

    Jianyong Wu, 86-13906523095, wujianyong1964@zju.edu.cn

    Recruiting

  • Changhai Hospital affiliated to Naval Military Medical University

    Shanghai

    Lei Zhang, 86-21-31162862, zl3514@139.com

    Recruiting

  • Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, 430030

    Lan Zhu, 86-27-83662882, zhulan@tjh.tjmu.edu.cn

    Recruiting

  • the First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

    Jin Zheng, PhD, 86-29-85323721, jzheng@xjtu.edu.cn

    Recruiting

Other trials in China

About this study

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

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?
Read more

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)
Keywords
kidney transplantation, rejection, infection, donor specific antibodies, cell-free DNA, Torque Teno Virus, immuno-monitoring
Medical subject headings
Virus Diseases, Rejection, Psychology, Infections

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Renal allograft biopsy and serum creatinine

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

    Measured: From day0 to day365 after kidney transplantation

Secondary outcomes (3)

  1. Infection event

    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

    Measured: From day0 to day365 after kidney transplantation

  2. donor-specific antibodies (DSA)

    the development of de novo DSA or a 30% increase of MFI value in preformed DSA

    Measured: From day0 to day365 after kidney transplantation

  3. donor derived cell-free DNA

    An increase in absolute or percent donor derived-cell free DNA from 1 month post-transplant

    Measured: From day0 to day365 after kidney transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2023
  2. Study start15 Mar 2023
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion30 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05727709
Sponsor's protocol ID
CTTV study
Acronym
TTV
Status last verified
Aug 2023
First submitted
5 Feb 2023
Last updated
22 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: all IPD that underlie results in a publication

Publications

  • 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.

    PubMed 24086067

  • 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.

    PubMed 29243394

  • 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.

    PubMed 34309698

  • 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.

    PubMed 24267896

  • 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.

    PubMed 30341363

  • 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.

    PubMed 30981537

  • 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.

    PubMed 31100359

  • 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.

    PubMed 30468687

  • 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.

    PubMed 29957546

  • 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.

    PubMed 31883425

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Transplant Rejection and Kidney Transplant Infection, run by Tongji Hospital at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gang Chen, PhD (+8613006187015, gchen@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Renal allograft biopsy and serum creatinine (time frame: From day0 to day365 after kidney transplantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05727709, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.

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