Immunosuppression Clinical Trial
— TTVOfficial title:
Dynamic Changes of Torquetenovirus Load in Chinese Renal Transplant Recipients During Immunosuppressive Therapy: A Double-blind Multicenter Prospective Observational Cohort Study
NCT number | NCT05727709 |
Other study ID # | CTTV study |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 15, 2023 |
Est. completion date | June 30, 2024 |
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)
Status | Recruiting |
Enrollment | 220 |
Est. completion date | June 30, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | West China Hospital,Sichuan University | Chengdu | |
China | The First Affiliated Hospital of Zhejiang University | Hangzhou | |
China | Changhai Hospital affiliated to Naval Military Medical University | Shanghai | |
China | Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology | Wuhan | |
China | the First Affiliated Hospital of Xi'an Jiaotong University | Xi'an |
Lead Sponsor | Collaborator |
---|---|
Tongji Hospital | Anapure BioScience, Caibo MedTech, SKM BioTech |
China,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | From day0 to day365 after kidney transplantation | |
Secondary | donor-specific antibodies (DSA) | the development of de novo DSA or a 30% increase of MFI value in preformed DSA | From day0 to day365 after kidney transplantation | |
Secondary | donor derived cell-free DNA | An increase in absolute or percent donor derived-cell free DNA from 1 month post-transplant | From day0 to day365 after kidney transplantation |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05060991 -
Impact of Immunosuppression Adjustment on COVID-19 Vaccination Response in Kidney Transplant Recipients
|
Phase 4 | |
Completed |
NCT02833805 -
NMA Haplo or MUD BMT for Newly Diagnosed Severe Aplastic Anemia
|
Phase 2 | |
Completed |
NCT01252537 -
Immunosuppression in HIV-infected Patients With Tuberculosis in Ethiopia
|
N/A | |
Completed |
NCT00621699 -
Pharmacokinetic Drug Interaction Between Ezetimibe and Tacrolimus After Single Dose Administration in Healthy Subjects
|
Phase 1 | |
Completed |
NCT01678937 -
Immune Tolerance and Alloreactivity in Liver Transplant Recipients on Different Monotherapy Immunosuppressive Agents
|
N/A | |
Completed |
NCT00788021 -
Protective Immunity Project 01
|
N/A | |
Active, not recruiting |
NCT00166842 -
Sirolimus Blood Concentrations on Conversion From Oral Solution to Tablets
|
Phase 4 | |
Recruiting |
NCT05616130 -
Pathological Myeloid Activation After Sepsis and Trauma
|
||
Completed |
NCT03117192 -
Zinc Supplementation on Cellular Immunity in Thalassemia Major
|
Phase 4 | |
Recruiting |
NCT01568697 -
Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)
|
||
Not yet recruiting |
NCT06024226 -
Role of MDSCs and Cancer Stem Cells and Their Cross Talks in NSCLC
|
||
Not yet recruiting |
NCT04961229 -
Booster Dose of COVID-19 Vaccine for Kidney Transplant Recipients Without Adequate Humoral Response
|
Phase 4 | |
Completed |
NCT03139565 -
High Dose vs. Standard Influenza Vaccine in Adult SOT
|
Phase 3 | |
Completed |
NCT02547753 -
Dental Extractions Among Renal Transplant Recipients
|
||
Completed |
NCT01702207 -
Evaluation Of Switching From Twice Daily Tacrolimus To Once Daily Formulation On Cardiovascular Risk
|
Phase 4 | |
Completed |
NCT00626808 -
A Post Marketing Evaluation of the Effectiveness of FluMist Risk Minimization Plan in Children
|
Phase 4 | |
Completed |
NCT00419575 -
Renal Transplantation With Immune Monitoring
|
N/A | |
Completed |
NCT00783380 -
Influenza Vaccination in Immunocompromized Patients
|
Phase 4 | |
Completed |
NCT04835948 -
Efficacy of Single Dose Anti-thymocyte Globulin in the Modulation of T Lymphocytes in Kidney Transplantation
|
||
Recruiting |
NCT05043870 -
Combined Immunosuppression for Pediatric Crohn's Disease
|
Phase 4 |