Kidney Transplant; Complications Clinical Trial
Official title:
Screening for HHV8 Infection in Solid Organ Transplantation Donors, Candidates and Recipients
Solid organ transplant candidates will undergo serological screening for HHV8 at time of listing and transplantation. In the event of a recipient/donor mismatch R-/D+ or in the presence of a seropositive recipient (R+), blood levels of HHV8 DNA will be monitored together with specific IGRA for HHV8.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | SOT DONORS: Inclusion Criteria: - all donors used for transplantation purposes (kidney, liver, lung), including living donors in case of kidney transplantation Exclusion Criteria: - None SOT CANDIDATES RECIPIENTS: Inclusion Criteria: - All patients listed for solid organ transplantation (lung, liver and kidney) Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano | Milan |
Lead Sponsor | Collaborator |
---|---|
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
Italy,
Chiereghin A, Barozzi P, Petrisli E, Piccirilli G, Gabrielli L, Riva G, Potenza L, Cappelli G, De Ruvo N, Libri I, Maggiore U, Morelli MC, Potena L, Todeschini P, Gibertoni D, Labanti M, Sangiorgi G, La Manna G, Pinna AD, Luppi M, Lazzarotto T. Multicenter Prospective Study for Laboratory Diagnosis of HHV8 Infection in Solid Organ Donors and Transplant Recipients and Evaluation of the Clinical Impact After Transplantation. Transplantation. 2017 Aug;101(8):1935-1944. doi: 10.1097/TP.0000000000001740. — View Citation
Pietrosi G, Vizzini G, Pipitone L, Di Martino G, Minervini MI, Lo Iacono G, Conaldi PG, Grossi P, Lamonaca V, Galatioto L, Gruttadauria S, Gridelli B. Primary and reactivated HHV8 infection and disease after liver transplantation: a prospective study. Am J Transplant. 2011 Dec;11(12):2715-23. doi: 10.1111/j.1600-6143.2011.03769.x. Epub 2011 Oct 3. — View Citation
Polizzotto MN, Uldrick TS, Wyvill KM, Aleman K, Marshall V, Wang V, Whitby D, Pittaluga S, Jaffe ES, Millo C, Tosato G, Little RF, Steinberg SM, Sereti I, Yarchoan R. Clinical Features and Outcomes of Patients With Symptomatic Kaposi Sarcoma Herpesvirus (KSHV)-associated Inflammation: Prospective Characterization of KSHV Inflammatory Cytokine Syndrome (KICS). Clin Infect Dis. 2016 Mar 15;62(6):730-738. doi: 10.1093/cid/civ996. Epub 2015 Dec 12. Erratum In: Clin Infect Dis. 2018 Mar 5;66(6):985. — View Citation
Riva G, Luppi M, Barozzi P, Forghieri F, Potenza L. How I treat HHV8/KSHV-related diseases in posttransplant patients. Blood. 2012 Nov 15;120(20):4150-9. doi: 10.1182/blood-2012-04-421412. Epub 2012 Sep 11. — View Citation
Tzannou I, Papadopoulou A, Naik S, Leung K, Martinez CA, Ramos CA, Carrum G, Sasa G, Lulla P, Watanabe A, Kuvalekar M, Gee AP, Wu MF, Liu H, Grilley BJ, Krance RA, Gottschalk S, Brenner MK, Rooney CM, Heslop HE, Leen AM, Omer B. Off-the-Shelf Virus-Specific T Cells to Treat BK Virus, Human Herpesvirus 6, Cytomegalovirus, Epstein-Barr Virus, and Adenovirus Infections After Allogeneic Hematopoietic Stem-Cell Transplantation. J Clin Oncol. 2017 Nov 1;35(31):3547-3557. doi: 10.1200/JCO.2017.73.0655. Epub 2017 Aug 7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of HHV8 seropositivity among SOT donors and recipients | Incidence of HHV8 seropositivity among solid organ transplantations donors, candidates and recipients | 2021-2024 | |
Primary | Incidence of HHV8 mismatch between SOT donors and recipients | Incidence of HHV8 mismatch between solid organ transplantations donors and recipients | 2021-2024 | |
Secondary | Incidence of HHV8 related disease after solid organ transplantation | Incidence of HHV8 related disease after solid organ transplantation | 2021-2025 |
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